Systems and methods for assuring quality compliance of point-of-care instruments used with single-use testing devices

ABSTRACT

The present invention relates to systems and methods of determining quality compliance for one or more biological sample testing instruments used with one or more type of single-use blood testing cartridge, at the point-of-care in a hospital, or other location that deliver medical care. In particular, the systems and methods ensure that only instruments that pass a quality assurance protocol are used for point-of-care testing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/171,689, filed on Jun. 5, 2015, the entirety of which is incorporatedherein by reference.

FIELD OF THE INVENTION

The technical character of the present invention relates to systems andmethods of determining quality compliance for one or more biologicalsample testing instruments used with one or more type of single-useblood testing cartridge, at the point-of-care in a hospital, or otherlocation that deliver medical care. In particular, the systems andmethods implement risk management to ensure that only instruments thatpass a quality assurance protocol are used for point-of-care testing.

BACKGROUND OF THE INVENTION

Point-of-care (POC) sample analysis systems are generally based on oneor more re-usable test instruments (e.g., a reading apparatus) thatperform sample tests using a single-use disposable testing device, e.g.,a cartridge or strip that contains analytical elements, e.g., electrodesor optics for sensing analytes such as pH, oxygen and glucose. Thedisposable testing device can include fluidic elements (e.g., conduitsfor receiving and delivering the sample to sensing electrodes oroptics), calibrant elements (e.g., aqueous fluids for standardizing theelectrodes with a known concentration of analyte), and dyes with knownextinction coefficients for standardizing optics. The instrument orreading apparatus contains electrical circuitry and other components foroperating the electrodes or optics, making measurements, and performingcomputations. The instrument or reading apparatus also has the abilityto display results and communicate those results to laboratory andhospital information systems (LIS and HIS, respectively), for example,via a computer workstation or other data management system.Communication between the instrument or reading apparatus and aworkstation, and between the workstation and a LIS or HIS, can be via,for example, an infrared link, a wired connection, wirelesscommunication, or any other form of data communication that is capableof transmitting and receiving electrical information, or any combinationthereof. A notable point-of-care system (The i-STAT® System, AbbottPoint of Care Inc., Princeton, N.J.) is disclosed in U.S. Pat. No.5,096,669, which comprises a disposable device, operating in conjunctionwith a hand-held analyzer, for performing a variety of measurements onblood or other fluids.

One benefit of point-of-care sample testing systems is the eliminationof the time-consuming need to send a sample to a central laboratory fortesting. Point-of-care sample testing systems allow a nurse or doctor(user or operator), at the bedside of a patient, to obtain a reliablequantitative analytical result, comparable in quality to that whichwould be obtained in a laboratory. In operation, the nurse selectstesting device with the required panel of tests, draws a biologicalsample from the patient, dispenses it into the testing device,optionally seals the testing device, and inserts the testing device intothe instrument or reading apparatus. While the particular order in whichthe steps occur may vary between different point-of-care systems andproviders, the intent of providing rapid sample test results close tothe location of the patient remains. The instrument or reading apparatusthen performs a test cycle, i.e., all the other analytical stepsrequired to perform the tests. Such simplicity gives the doctor quickerinsight into a patient's physiological status and, by reducing the timefor diagnosis or monitoring, enables a quicker decision by the doctor onthe appropriate treatment, thus enhancing the likelihood of a successfulpatient outcome.

In the emergency room and other acute-care locations within a hospital,the types of sample tests required for individual patients tend to vary.Thus, point-of-care systems generally offer a range of disposabletesting devices with different sample tests, or combinations of tests.For example, for blood analysis devices, in addition to traditionalblood tests, the different sample tests may include oxygen, carbondioxide, pH, potassium, sodium, chloride, hematocrit, glucose, urea,creatinine and calcium, other tests can include, for example,prothrombin time (PT), activated clotting time (ACT), activated partialthromboplastin time (APTT), cardiac troponin I (cTnI), brain natriureticpeptide (BNP), creatine kinase MB (CKMB) and lactate. While devicestypically contain between one and ten tests, it should be appreciated bypersons of ordinary skill in the art that any number of tests may becontained on a device. For example, a device for genetic screening mayinclude numerous tests. To illustrate the need for different devices, apatient suspected of arrhythmia may require a device with a testcombination that includes a potassium test, whereas a patient suspectedof a diabetic hypoglycemia may require a device with a test combinationthat includes a glucose test. An emergency room will need to havesufficient inventory of both types of testing device to meet theanticipated workload.

For hospitals, the introduction of point-of-care testing capabilitieshas created unique requirements and issues for quality compliance,system and operator verification, and process management. These issuesarise from the use of one or more test instruments running multipletypes of disposable sample testing devices at various locations within ahospital. Consequently, a hospital must provide an adequate supply ofeach type of device at each site of use, while ensuring the devices arewithin their usable shelf-life, along with also ensuring that theinstruments are performing to specification. The Clinical LaboratoryImprovement Amendments (CLIA) regulate laboratory testing and requireclinical laboratories implementing point-of-care sample analysis systemsto be certificated by their state as well as the Center for Medicare andMedicaid Services (CMS) before they can accept human samples fordiagnostic testing. CLIA has established minimum standards for allnon-waived laboratory testing, including specific regulations forquality control.

To achieve the goal of quality control, including the precision andaccuracy of test results, it is necessary to be able to detect errorswithin the point-of-care systems as soon as possible. Conventionally,many point-of-care testing devices include unit-use cartridges and teststrips (e.g., single-use disposable testing devices). With unit-useformats, analysis of liquid quality control can verify the performanceof an individual test, but the analysis of liquid quality controlconsumes the test strip or cartridge and cannot guarantee the quality oftests from other strips or cartridges. Thus, unit-use tests oftencontain internal control processes built into each test to ensure resultquality on each strip or cartridge. For example, U.S. Pat. No. 6,512,986discloses a method of processing test results to detect any random andsystemic exception from historical test results that have previouslybeen stored. Further, U.S. Patent Application Publication No.2002/0116224 discloses a networked expert system for automatedevaluation and quality control of point-of-care laboratory measuringdata.

However, with many point-of-care testing systems, issues arise instriking a balance between the use of liquid quality control and thereliance on internal control processes built into each test. Forexample, should an operator of a point-of-care testing device have touse liquid control for each reaction occurring on a sensing chip eachday of testing, this could be cost prohibitive and duplicative ofinternal control processes built into the point-of-care testing system.With so many different point-of-care testing devices and controlprocesses available, laboratories need a systematic approach to ensurequality and strike the right balance of liquid quality control inconcert with internal control processes. This approach is known as riskmanagement.

The Clinical and Laboratory Standards Institute (CLSI) guideline EP-23introduces risk management principles to the clinical laboratory. CLISEP23 describes good laboratory practice for developing a quality controlplan based on the manufacturer's risk information, applicable regulatoryand accreditation requirements, and the individual healthcare andlaboratory setting. This guideline helps laboratories identifyweaknesses in the testing process that could lead to error and explainshow to develop a plan to detect and prevent those errors from happening.The CMS has incorporated key elements of risk management from CLSI EP23into the new CLIA interpretive guidelines that offer a quality controloption called an Individualized Quality Control Plan (IQCP).Specifically, laboratory tests, including point-of-care testing, nowhave two options for defining the frequency of quality control fornon-waved testing (e.g., moderate- and high-complexity tests) includingeither two concentrations of liquid quality control each day, ordeveloping an IQCP.

IQCPs are valuable to laboratories or medical care facilities that usesingle unit-use point-of-care devices and instrumentation with built-incontrol processes. The primary objective of IQCPs is not to reduce thefrequency of analyzing liquid quality control, but rather to ensure theright quality control to address a laboratory's or medical carefacility's specific risks and ensure quality test results. In thecontext of point-of care testing, laboratories or medical carefacilities may incorporate both internal and external control processes.Each device is unique, operates differently, and offers specific controlprocesses engineered into the test. And since no single control processcan cover all potential risks, a laboratory's or medical care facility'squality control plan should incorporate a mix of internal controls andtraditional liquid quality control.

Each test may require a specific IQCP, because devices are different andpresent unique risks. However, a single risk assessment and IQCP couldcover multiple tests conducted on the same instrument, provided the IQCPfactors in the differences unique to each analyte. For instance, asingle IQCP for a chemistry analyzer could cover all tests conducted onthat analyzer, since instrument operation, risk of error, andfunctionality of control processes is shared amongst all analytes on thesame analyzer. IQCPs should benefit medical care facilities in a numberof ways. For example, laboratories or medical care facilities usingsingle unit-use devices may define an optimum frequency of liquidquality control in conjunction with a manufacturer's control processes.For unit-use blood gas and coagulation devices, medical care facilitiescan be more efficient by analyzing quality control for lots of reagentsusing a subset of devices rather than every device available, since thechemistry of the test is in the unit-use strip or cartridge—not in thedevice, which acts as a volt-meter or timer. For molecular arrays andlabs-on-a-chip, analyzing liquid quality control across each reactionmay be less effective than controlling the processes of greatest risk,such as quality and amount of sample, viability of replicating enzyme,and temperature cycling.

Quality control programs, especially point-of-care quality controlprograms, which monitor numerous instruments and types of devicesinterconnected within a network, tend to yield large volumes of qualitycontrol information obtained from numerous point-of-care locationswithin the network. Accordingly, several computer implemented methodshave been proposed to process the large volumes of quality controlinformation. These computer implemented methods often include processesfor determining potential quality control compliance issues. However,the performance of risk management to ensure quality and strike theright balance of liquid quality control in concert with internal controlprocesses has not been adequately addressed. Nor has there been aquality control program implemented using a centrally managed systemthat ensures only biological sample testing devices that pass a qualityassurance protocol are used for point-of-care testing.

For example, U.S. Pat. Nos. 6,856,928 and 6,512,986 disclose a methodfor analyzing data from point-of-care testing to identify when thetesting exceeds a variation expected under stable operation (i.e., thetesting is “out of control”). The method includes storing test resultsreceived from each of a plurality of point-of-care devices, including anassociation with the operator of the point-of-care device and/or areagent used in obtaining the test results. The method further includesprocessing the results to detect any random and/or systemic exceptionfrom results that have previously been stored, and automaticallydisabling a questionable point-of-care device based on detection of aquality control compliance exception This method, however, is predicatedon quality control rules, such as Westgard Rules, for automaticallydisabling a particular point-of-care device based on detection of anexception, and does not strike a balance of the liquid quality controlin concert with internal control processes nor ensure only biologicalsample testing devices that pass a quality assurance protocol are usedfor point-of-care testing.

U.S. Pat. No. 8,495,707 discloses system for quality assured analyticaltesting. The system includes an Instrument Management System and ananalytical instrument for conducting analytical testing, the analyticalinstrument having an input section for determining an actual user of theinstrument and the analytical instrument being configured to run atesting routine. The system further includes a terminal connected to theInstrument Management System, which is remote from the analyticalinstrument and which provides an examination module of the InstrumentManagement System that is programmed to conduct an exam during which theexamination module prompts questions to the user via the terminal whichrelate to the analytical instrument and/or a diagnostic test to beconducted therewith, receive and evaluate answers to the exam, andtransmit a user certificate to the analytical instrument if the userpassed the exam such that a user may access a testing routine. Thismethod, however, is predicated on control of instrument usage so thatonly well-educated users with proven knowledge are allowed to performtesting with the analytical instrument, and does not strike a balance ofliquid quality control in concert with the knowledge testing nor ensureonly biological sample testing devices that pass a quality assuranceprotocol are used for point-of-care testing.

U.S. Patent Application Publication No. 2004/0173456 discloses a systemfor point-of-care diagnosis including a cartridge for analysis, wherecartridge-specific data are evaluated for the respective concentrationvalues in accordance to the cartridge specific data and information.Additionally, U.S. Pat. No. 7,824,612 discloses a body fluid analyzerwith a data storage unit that contains information concerning aparticular drug being taken by a patient, and a processor for setting athreshold value for an analyte to be sensed by a sensing unit and adisplay for displaying an alert. As with other disclosed methods ofpoint-of-care quality control programs, these methods do not strike abalance of liquid quality control in concert with internal controlprocesses nor ensure only biological sample testing devices that pass aquality assurance protocol are used for point-of-care testing.

In view of the above-noted limitations of conventional point-of-caretesting systems and the recent implementation of IQCPs by manylaboratories and medical care facilities, there remains a need forsystems and methods of determining quality compliance for a set ofbiological sample testing devices, e.g., single-use blood testingcartridges, used with one or more test instruments at the point-of-carein a hospital or other location for delivering medical care, where thesystems and methods implement risk management to ensure that onlydevices that pass a quality assurance are used for point-of-caretesting.

SUMMARY OF THE INVENTION

In one embodiment, the present invention is directed to a methodimplemented in a computer infrastructure having computer executable codetangibly embodied on one or more non-transitory storage devices havingprogramming instructions. The programming instructions are operable totransmit a requirement for instrument calibration verification from adata manager to one or more instruments based on a predeterminedschedule, and in response to the request for the instrument calibrationverification, perform the instrument calibration verification using: (i)a predetermined number and type of calibration fluids, a predeterminednumber of sample testing cartridges of a set of sample testingcartridges, and the one or more instruments, or (ii) an electronicsimulator, to generate calibration verification data. The programminginstructions are further operable to transmit the calibrationverification data from the one or more instruments to the data manager,determine a compliance status of the one or more instruments at the datamanager based on whether the calibration verification data is withinrange of predetermined calibration target values, store the determinedcompliance status for the one or more instruments in a data table, andtransmit the data table from the data manager to each of the one or moreinstruments. The programming instructions are further operable to enableuse of the one or more instruments for performing one or more analyticaltests on biological samples when the compliance status stored in thedata table indicates the one or more instruments are in compliance, andat least partially disable use of the one or more instruments forperforming the one or more analytical tests on the biological sampleswhen the compliance status stored in the data table indicates the one ormore instruments are not in compliance.

In some embodiments, the programming instructions are further operableto receive attributes at each of the one or more instruments from thedata manager. The attributes including the predetermined number and typeof calibration fluids and the predetermined number of testing cartridgesof the set of sample testing cartridges. Optionally, the programminginstructions are further operable to receive an instrument configurationprofile at the data manager from a configuration manager. Theconfiguration profile including the predetermined calibration targetvalues.

In other embodiments, the one or more analytical tests are configured todetect one or more analytes selected from the group consisting of:sodium, potassium, chloride, total carbon dioxide, ionized calcium,glucose, blood urea nitrogen (BUN), creatinine, lactate, hematocrit, pH,partial pressure of carbon dioxide, partial pressure of oxygen, troponinI, troponin T, creatine kinase MB, procalcitonin, beta human chorionicgonadotropin (bHCG), human chorionic gonadotropin (HCG), N-terminal ofthe prohormone brain natriuretic peptide (NTproBNP), prohormone brainnatriuretic peptide (proBNP), brain natriuretic peptide (BNP),myoglobin, parathyroid hormone, d-dimer, neutrophilgelatinase-associated lipocalin (NGAL), galectin-3, and prostatespecific antigen (PSA).

In additional or alternative embodiments, the programming instructionsare further operable to generate the predetermined schedule comprising ascheduled time for the instrument calibration verification for each ofthe one or more instruments. The requirement for the instrumentcalibration verification is transmitted in accordance with thepredetermined schedule.

In one embodiment, the present invention is directed to a systemcomprising a set of sample testing cartridges, and a plurality ofanalyzers in communication with one another via a wireless network. Eachof the plurality of analyzers is configured to perform analyzercalibration verification in response to receiving a requirement for theanalyzer calibration verification from a data manager based on apredetermined schedule, wherein the analyzer calibration verification isperformed using: (i) a predetermined number and type of calibrationfluids and a predetermined number of sample testing cartridges of theset of sample testing cartridges, or (ii) an electronic simulator, togenerate calibration verification data. Each of the plurality ofanalyzers is also configured to transmit the calibration verificationdata. The system further comprises a data manager that is incommunication with each of the plurality of analyzers via the wirelessnetwork. The data manager is configured to determine a compliance statusof each of the plurality of analyzers based on whether the calibrationverification data is within range of predetermined calibration targetvalues, store the determined compliance status for each of the pluralityof analyzers in a data table, and transmit the data table to each of theplurality of analyzers. Each of the plurality of analyzers is furtherconfigured to when the compliance status stored in the data tableindicates an analyzer is in compliance, enable use of the analyzer forperforming one or more analytical tests on biological samples, and whenthe compliance status stored in the data table indicates the analyzer isnot in compliance, at least partially disable use of the analyzer forperforming the one or more analytical tests on the biological samples.

In some embodiments, the system further comprises a configurationmanager configured to obtain the predetermined calibration targetvalues, and transmit an analyzer configuration profile including thepredetermined calibration target values to the data manger. Optionally,the data manager is further configured to transmit attributes to each ofthe plurality of analyzers, the attributes including the predeterminednumber and type of calibration fluids and the predetermined number oftesting cartridges of the set of sample testing cartridges.

In other embodiments, the data manager is further configured to generatethe predetermined schedule comprising a scheduled time for the analyzercalibration verification for each of the plurality of analyzers,transmit the requirement for the analyzer calibration verification inaccordance with the predetermined schedule, and reset the scheduled timefor the analyzer calibration verification for each of the plurality ofanalyzers when the determined compliance status indicates each of theplurality of analyzers are in compliance.

In one embodiment, the present invention is directed to a computerimplemented method comprising in response to a request for theinstrument calibration verification, performing one or more qualitycontrol tests to generate calibration verification data, the one or morequality control tests being performed using: (i) a predetermined numberand type of calibration fluids, (ii) a predetermined number of sampletesting cartridges of a set of sample testing cartridges, and (iii) atleast one analyzer of a plurality of analyzers. The method furthercomprising transmitting the calibration verification data to a datamanager, and receiving a data table from the data manager. The datatable comprising a compliance status for the at least one analyzer thatis determined based on the calibration verification data The methodfurther comprising enabling use of the at least one analyzer forperforming one or more analytical tests on biological samples when thecompliance status stored in the data table indicates the at least oneanalyzer is in compliance, and at least partially disabling use of theat least one analyzer for performing the one or more analytical tests onthe biological samples when the compliance status stored in the datatable indicates the at least one analyzer is not in compliance.

In another embodiment, the present invention is directed to a computerimplemented method comprising in response to a request for theinstrument calibration verification, performing one or more qualitycontrol tests to generate calibration verification data, the one or morequality control tests being performed using an electronic simulator, andtransmitting the calibration verification data to a data manager. Themethod further comprises receiving a data table from the data manager,the data table comprising a compliance status for the at least oneanalyzer that is determined based on the calibration verification data,enabling use of the at least one analyzer for performing one or moreanalytical tests on biological samples when the compliance status storedin the data table indicates the at least one analyzer is in compliance,and disabling use of the at least one analyzer for performing the one ormore analytical tests on the biological samples when the compliancestatus stored in the data table indicates the at least one analyzer isnot in compliance.

In one embodiment, the present invention is directed to a portableclinical analyzer for in vitro analysis. The analyzer comprises a portconfigured to receive a sample testing cartridge of a set of sampletesting cartridges. The analyzer further comprises a computing deviceconfigured to in response to a request for the instrument calibrationverification, performing one or more quality control tests to generatecalibration verification data, the one or more quality control testsbeing performed using: (i) a predetermined number and type ofcalibration fluids and a predetermined number of sample testingcartridges of the set of sample testing cartridges, or (ii) anelectronic simulator. The computing device is further configured totransmit the calibration verification data to a data manager, andreceive a data table from the data manager, the data table comprising acompliance status for the portable clinical analyzer that is determinedbased on the calibration verification data. The computing device isfurther configured to enable use of the portable clinical analyzer forperforming one or more analytical tests on biological samples when thecompliance status stored in the data table indicates the portableclinical analyzer is in compliance, and at least partially disable useof the portable clinical analyzer for performing the one or moreanalytical tests on the biological samples when the compliance statusstored in the data table indicates the portable clinical analyzer is notin compliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be better understood in view of the followingnon-limiting figures, in which:

FIG. 1 shows an isometric view of a disposable sensing device and readerdevice in accordance with some aspects of the invention;

FIG. 2 shows an exploded view of a cartridge in accordance with someaspects of the invention;

FIG. 3 is an illustrative external environment for implementing theinvention in accordance with some aspects of the invention;

FIG. 4 is a block diagram illustrating a high level architecture of anexemplary quality control system for a point-of-care diagnostictechnology, in accordance with some aspects of the invention; and

FIGS. 5-8 are illustrative process flow diagrams for implementing thesystem in accordance with some aspects of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Introduction

A typical point-of-care testing program in an institution may have tensor hundreds of non-laboratory operators with wide ranges of education,training, responsibilities, and understanding of medical conditions andthe indications and implications of medical testing. A challenge of anyprogram for quality control compliance for technologies used forpoint-of-care blood testing is to assure the technology is compatiblewith the operator skill levels of those who use the technology.Typically, this is a responsibility of a quality compliance manager inpartnership with nursing and other clinical personnel, who construct aquality control system for a medical care facility. To be effective, thetechnology should be practical and simple to understand. Accordingly,some aspects of the present invention are directed to providing aconfiguration manager configured to help quality compliance managers toefficiently and effectively construct, implement, and maintainmeaningful quality control systems and processes.

More specifically, some embodiments of the present invention aredirected to utilizing a configuration manager to develop and implement aprogram for quality control compliance of technologies that utilizepoint-of-care sample testing. The program for quality control complianceincludes a plurality of attributes that are configurable to ensure thata right amount and type of quality control is implemented to address alaboratory's or medical care facility's specific risks and ensurequality test results. For example, the plurality of attributes may beconfigured to include procedures for assessing risk and quality asinstructed by the CLSI EP23. The plurality of attributes may also beconfigured to include procedures for the review of incoming qualitycontrol test results, intermediate quality control test results,proficiency testing results, and preventive maintenance records (e.g.,this may include recording all of the test results obtained by anoperator and monitoring the results for inaccuracies).

While performing a quality control test function on a single instrumentwith a single test device using one or more quality control liquids orfluids is standard practice in the art of blood testing, there iscurrently no global solution to the issue of managing multipleinstruments at distributed locations (and test device types) in asimple, convenient and cost-effective manner. The technical solution ofthe present invention overcomes this problem using a centrally manageddata manager that is networked with each instrument. More specifically,in the present invention, quality control of a network of instruments iscoordinated and managed by a centrally managed data manager inaccordance with the procedures defined by a configuration manager. Thistechnology has utility for incoming quality control when cartridges aredelivered from a manufacture or supplier to a customer, and forintermittent or daily quality control during the time the cartridges areat a customer site before they exceed an expiration date. The advantageof the aforementioned technical solution is of great benefit to alaboratory or medical care facility, such as a hospital, as thecentrally managed data manager can use the quality control data from oneinstrument quality control procedure to update a compliance status forspecific devices or cartridges on all the instruments that are networkedtogether, e.g., all the analytical instruments of one type in ahospital. Moreover, the centrally managed data manager can globallycontrol the quality control procedures for each of the instrumentswithin the network.

A central data management system that comprises the aforementionedconfiguration manager is configured to automatically keep track of theplurality of attributes, compliance thresholds or target values (e.g., ameans for evaluating compliance or non-compliance with operation of theinstruments), and quality control records associated with eachinstrument and/or testing device within the program for quality controlcompliance. In some embodiments, the central data management system mayalso keep track of records for each operator within the testing programusing an operator tracking record and/or profile system. The qualitycontrol records may include instrument identifiers (e.g., a serialnumber for the instrument), analytical test results, clinical controlresults, proficiency test results, operator identifiers, etc. Theproficiency tests or proficiency test results may pertain to testing ofpreviously analyzed specimens with known concentrations of analyte,internal blind testing samples, or external proficiency testing samplesconfigured for statistical quality assurance programs that enablelaboratories to assess their performance in conducting test methods.

The advantage of the aforementioned technical solution for centrallymanaging and implementing a program for quality control compliance isthat it will eliminate the technical problems of having to perform adefault frequency of two levels of quality control each day on eachunit-use test device with liquid quality control and an inability tobalance the default frequency of two levels of quality control withunit-use test devices that include internal control systems andprocesses built into each unit-use test device. For example,implementations of the present invention provide a technicalcontribution over conventional quality control systems and methodsbecause the technical features of the present invention interoperate toenable or disable use of a set or lot of testing devices by some (e.g.,a subset) or all of the instruments in a network based on a plurality ofattributes using a centralized computing environment to ensure qualityacross the network of instruments and strike the right balance of liquidquality control in concert with internal control processes.

Biological Sample Test System

The present invention relates to a handheld In-Vitro Diagnostic (IVD)instrument system including a self-contained disposable sensing deviceor cartridge (device(s)) and a reader or analyzer (instrument(s)configured for use at a patient bedside. A fluid sample to be measuredis drawn into a sample entry orifice or port in the cartridge and thecartridge is inserted into the analyzer through a slotted opening orport. Measurements performed by the analyzer are output to a display orother output device, such as a printer or data management system via aport on the analyzer to a computer port. Transmission can be via Wi-Fi,Bluetooth link, infrared and the like. For example, the handheld IVDinstrument system may be of similar design to the systems disclosed inU.S. Pat. Nos. 5,096,669 and 7,419,821, both of which are incorporatedherein by reference in their entireties.

More specifically, a system and method are disclosed for operating aplurality of point-of-care diagnostic test devices (e.g., cartridges).Each device may be configured to perform at least one biological sampleanalysis, e.g., blood, plasma, urine tests and the like, and each devicemay have a usable lifetime denoted for example by an expiration date.FIG. 1 shows the component parts and interactions of a typicalpoint-of-care system. The system 100 may include a reading apparatus102, a disposable device 103, a central data station or data manager 104and a box of devices 105. The reading apparatus 102 may include, forexample, a display 106, electronic memory and a keypad 107 for manualdata entry. The disposable device 103 may include, for example, a port108 for receiving a patient sample, and the device 103 may be insertedinto the reading apparatus 102 through a slotted opening 109. Thereading apparatus 102 may communicate with the central data manager 104using, for example, a wireless connection, an infrared link, an opticallink, a network connection 110, 111, or any other form of communicationlink that uses any form of communication protocol to transferinformation.

The reading apparatus 102 may include a barcode reader for readinginformation from a patient's bar-coded wristband, from a barcode on adevice 103 or from any other item (e.g., the box of devices 105, box ofcontrol fluids, etc.) used in conjunction with the reading apparatus102. Other such encoding arrangements can be used. For example, thereading apparatus 102 may also include (either alternatively or inaddition to the barcode reader) a radio-frequency (RF) identificationdevice that is capable of identifying an RF tag that is contained on orin each individual device or each box of devices 105. According toanother exemplary embodiment of the present invention, one or more ofthe encoding arrangements may be based upon a binary coding pin array ofthe type disclosed in, for example, U.S. Pat. No. 4,954,087, which isincorporated herein by reference in its entirety.

The various encoding arrangements may convey relevant information suchas, for example, the identity of a specific device type, date andlocation of manufacture, manufacturing lot number, expiration date, aunique number associated with a device, coefficients for use by thereading apparatus 102 associated with the calculation of blood or othersample parameters, and the like. The device 103 may be used formeasurements selected from groups such as, for example, amperometric,potentiometric, conductimetric, optical, and the like. Other relevantinformation of this general type is well known in the medicalmanufacturing art, as is the technology for bar coding and barcoderecognition.

Other information encoded with the device 103 may include therefrigerator shelf life, the ambient temperature shelf life, the age ofthe device and the like. Alternatively, rather than including numerouselements of relevant information, a single piece of information, e.g., alot number, may be included. The lot number may be any alphanumericsequence or unique identifier that can be used to identify the device103 and associate relevant information with that device, e.g. qualitycontrol attributes. For example, the lot number can be applied to alookup table or any other type of computer database located within orconnected to the reading apparatus 102 or any other computing system,e.g., the data manager 104. Using the lookup table or computer database,relevant shelf life or other such information can be associated with thelot number such that, based on the lot number, the refrigerator shelflife, the ambient temperature shelf life, the age of the device 103 andthe like can be determined. Other quality control data or attributes mayalso be included.

The devices 103 may have a finite refrigerator and ambient temperatureshelf life. For example, the devices 103 may have a refrigerated usablelifetime in the range of, for example, about three months to threeyears, although the devices 103 could have any range of refrigeratedusable lifetime. The devices 103 may have an ambient temperature usablelifetime in the range of, for example, about three days to three months,although the devices 103 can have any range of ambient temperatureusable lifetime. Given that the devices 103 may have a finiterefrigerator and ambient temperature shelf life, there may be a need toensure that expired devices 103 (e.g., the devices 103 that haveexceeded the refrigerated or ambient temperature shelf life) are notused.

Referring to the disposable device 103 and the patient sample entry port108, the device 103 may perform analyses on a range of biological sampletypes. These sample types may include, for example, blood, plasma,serum, sputum, cerebrospinal fluid, tears, urine, body tissue, fecalmatter, and the like. Appropriate consumable items for use inconjunction with the device 103 are well known in the art. Theseinclude, for example, vacutainers, needles, capillary tubes andcollection devices, control fluids of different types, syringes, swabs,printer paper, batteries and any other consumable item that can be usedin conjunction with the device 103. The consumable items can also beused to facilitate introduction of the sample into the sample entry port108.

The reading apparatus 102 may include a microprocessor (e.g., any typeof processor). The reading apparatus may also include any type ofcomputer memory or any other type of electronic storage medium that islocated either internally or externally to the reading apparatus 102,such as, for example, a random access memory (RAM). According toexemplary embodiments, the RAM may contain, for example, the operatingprogram for the reading apparatus 102. As will be appreciated based onthe following description, the RAM can, for example, be programmed usingconventional techniques known to those having ordinary skill in the artof computer programming. The actual source code or object code forcarrying out the steps of, for example, a computer program can be storedin the RAM.

The reading apparatus 102 may include a communications port 110 (e.g.,any type of communications port through which electronic information canbe communicated over a communications connection, whether locally orremotely) with which the reading apparatus 102 can communicate with, forexample, the data manager 104. The reading apparatus 102 may alsoinclude the input port 109 that, for example, allows insertion of thedevice 103 and is appropriately configured to receive the device 103.The reading apparatus 102 may also include a user interface 106, 107.The user interface 106, 107 may be any type of computer monitor ordisplay device on which graphical and/or textual information can bedisplayed to a user (e.g., through a graphical user interface) and whichallows a user to enter information (e.g., commands and the like)through, for example, a keyboard, a touch-screen, any type of pointingdevice, electronic pen, and the like. For example, the user interface106, 107 can be configured to receive instructions from the operator ofthe reading apparatus 102. It should also be appreciated that, while asingle reading apparatus 102 is described above; multiple readingapparatus 102 can be included within a system where each is connected tothe data manager 104. Typically, each department within a hospital mayhave one or more readers.

It should further be appreciated by persons of ordinary skill in the artthat the devices 103, may in fact be a plurality with each type capableof being used for a different test. The devices 103 can include, forexample, blood analysis devices, urine analysis devices, serum analysisdevices, plasma analysis devices, saliva analysis devices, cheek swabanalysis devices, or any other type of disposable diagnostic device thatcan be used for point-of-care sample testing.

The data manager 104 may be configured to provide connectivity betweenindividual reading apparatus 102 and central locations, such as, forexample, a LIS or HIS (laboratory or hospital information system), anddevice 103. The data manager 104 may be connected with the varioussystem constituents using any type of communications connection that iscapable of transmitting and receiving electronic information, such as,for example, an Ethernet connection or other computer networkconnection. The data manager 104 can also optionally provide a directlink back to a vendor's (product manufacturer) information system, forexample via the Internet, a dial-up connection or other direct orindirect communication link, or through the LIS or HIS. Such anexemplary embodiment can provide for automated re-ordering of devices103 to maintain the predetermined levels of inventory at a hospital andallow the vendor to forecast demand and adequately plan the manufactureof the devices 103. It can also provide a means for updating deviceinformation, e.g. cartridge attributes and profiles, and control fluidinformation, e.g. expected analyte test ranges.

Exemplary Device or Cartridge

FIG. 2 shows an exploded view of cartridge 120 as described in U.S.Patent Application Publication No. 2011/0150705 and U.S. PatentApplication Publication No. 2013/0343955, both of which are incorporatedherein in their entireties. The cartridge 120 comprises a sample entryport 125, at least one sensor 130 (e.g., an electrochemical sensor, animmunosensor, a hematocrit sensor, a conductivity sensor, etc.), and apouch 135 containing a fluid, e.g., a sensor-standardization,calibration fluid, and/or wash fluid. The at least one sensor 130 may besubstantially aligned to a plane parallel to a horizontal plane of thebase of the analyzer. A recessed region 140 of the cartridge 120preferably includes a spike 145 configured to rupture the pouch 135,upon application of a force upon the pouch 135, for example, by theanalyzer 102 (shown in FIG. 1). Once the pouch 135 is ruptured, thesystem is configured to deliver the fluid contents from the pouch 135into a conduit 150. Movement of the fluid into and through the conduit150 and to a sensor region 155 (e.g., a conduit comprising the at leastone sensor 130 and a sensing reagent for the sensor) may be effected bya pump, e.g., a pneumatic pump connected to the conduit 150. Preferably,the pneumatic pump comprises a displaceable membrane 160. In theembodiment shown in FIG. 2, the cartridge 120 or test device may beconfigured to pump fluid via the displaceable membrane 160 from theruptured pouch 135 and the sample entry port 125 through the conduit 150and over the sensor region 155. The at least one sensor 130 generateselectric signals based on a concentration of specific chemical speciesin the sample, e.g., performs an electrolyte, metabolite, blood gas orimmunoassay on a blood sample from a patient.

The analytes/properties to which the at least one sensor respondsgenerally may be selected from among sodium, potassium, chloride, totalcarbon dioxide, ionized calcium, glucose, blood urea nitrogen (BUN),creatinine, lactate, hematocrit, pH, partial pressure of carbon dioxide,partial pressure of oxygen, troponin I, troponin T, creatine kinase MB,procalcitonin, beta human chorionic gonadotropin (bHCG), human chorionicgonadotropin (HCG), N-terminal of the prohormone brain natriureticpeptide (NTproBNP), prohormone brain natriuretic peptide (proBNP), brainnatriuretic peptide (BNP), myoglobin, parathyroid hormone, d-dimer,neutrophil gelatinase-associated lipocalin (NGAL), galectin-3, andprostate specific antigen (PSA). Preferably, the analyte is tested in aliquid sample that is whole blood, however other samples can be usedincluding blood, plasma, serum, sputum, cerebrospinal fluid, tears,urine, body tissue, and fecal matter and amended forms thereof.Amendments can include diluents and reagents such as anticoagulants andthe like.

System Environment

As will be appreciated by one skilled in the art, aspects of the presentinvention may be embodied as a system, method, or computer programproduct. Accordingly, aspects of the present invention may take the formof an entirely hardware embodiment, an entirely software embodiment(including firmware, resident software, micro-code, etc.) or anembodiment combining software and hardware aspects that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, aspects of the present invention may take the form of acomputer program product embodied in one or more computer readablemedium(s) having computer readable program code embodied thereon, e.g.residing on a data manager.

Any combination of one or more computer readable medium(s) may beutilized. The computer readable medium may be a computer readable signalmedium or a computer readable storage medium. A computer readablestorage medium may be, for example, but not limited to, an electronic,magnetic, optical, electromagnetic, infrared, or semiconductor system,apparatus, or device, or any suitable combination of the foregoing. Morespecific examples (a non-exhaustive list) of the computer readablestorage medium would include the following: an electrical connectionhaving one or more wires, a portable computer diskette, a hard disk,RAM, a read-only memory (ROM), an erasable programmable read-only memory(EPROM or Flash memory), an optical fiber, a portable compact discread-only memory (CD-ROM), an optical storage device, a magnetic storagedevice, or any suitable combination of the foregoing. In the context ofthis document, a computer readable storage medium may be any tangiblemedium that can contain, or store a program for use by or in connectionwith an instruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signalwith computer readable program code embodied therein, for example, inbaseband or as part of a carrier wave. Such a propagated signal may takeany of a variety of forms, including, but not limited to,electro-magnetic, optical, or any suitable combination thereof. Acomputer readable signal medium may be any computer readable medium thatis not a computer readable storage medium and that can communicate,propagate, or transport a program for use by or in connection with aninstruction execution system, apparatus, or device.

Program code embodied on a computer readable medium may be transmittedusing any appropriate medium, including but not limited to wireless,wireline, optical fiber cable, RF, etc., or any suitable combination ofthe foregoing.

Computer program code for carrying out operations for aspects of thepresent invention may be written in any combination of one or moreprogramming languages, including an object oriented programming languagesuch as Java, Smalltalk, C++ or the like and conventional proceduralprogramming languages, such as the “C” programming language or similarprogramming languages. The program code may execute entirely on theuser's computer, partly on the user's computer, as a stand-alonesoftware package, partly on the user's computer and partly on a remotecomputer or entirely on the remote computer or server. In the latterscenario, the remote computer may be connected to the user's computerthrough any type of network, including a local area network (LAN) or awide area network (WAN), or the connection may be made to an externalcomputer (for example, through the Internet using an Internet ServiceProvider).

Aspects of the present invention are described with reference toflowchart illustrations and/or block diagrams of methods, apparatus(systems) and computer program products according to embodiments of theinvention. It will be understood that each block of the flowchartillustrations and/or block diagrams, and combinations of blocks in theflowchart illustrations and/or block diagrams, can be implemented bycomputer program instructions. These computer program instructions maybe provided to a processor of a general purpose computer, specialpurpose computer, or other programmable data processing apparatus toproduce a machine, such that the instructions, which execute via theprocessor of the computer or other programmable data processingapparatus, create means for implementing the functions/acts specified inthe flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computerreadable medium that can direct a computer, other programmable dataprocessing apparatus, or other devices to function in a particularmanner, such that the instructions stored in the computer readablemedium produce an article of manufacture including instructions whichimplement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer,other programmable data processing apparatus, or other devices to causea series of operational steps to be performed on the computer, otherprogrammable apparatus or other devices to produce a computerimplemented process such that the instructions which execute on thecomputer or other programmable apparatus provide processes forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks.

FIG. 3 shows an illustrative environment 200 for managing the processesin accordance with the invention. To this extent, the environment 200includes a server or other computing system 212 that can perform theprocesses described herein. In particular, the server 212 includes acomputing device 214 (e.g., the data manager 104). The computing device214 can be resident on a network infrastructure or computing device of athird party service provider (any of which is generally represented inFIG. 3).

The computing device 214 also includes a processor 220, memory 222A, anI/O interface 224, and a bus 226. The memory 222A can include localmemory employed during actual execution of program code, bulk storage,and cache memories which provide temporary storage of at least someprogram code in order to reduce the number of times code must beretrieved from bulk storage during execution. In addition, the computingdevice 214 includes RAM, ROM, and an operating system (O/S).

The computing device 214 may be in communication with an external I/Odevice/resource 228 and the storage system 222B. For example, the I/Odevice 228 can comprise any device that enables an individual tointeract with the computing device 214 or any device that enables thecomputing device 214 to communicate with one or more other computingdevices using any type of communications link. The external I/Odevice/resource 228 may be for example, a handheld device, PDA, handset,mechanical keyboard, etc.

In general, the processor 220 executes computer program code (e.g.,program control 244), which can be stored in the memory 222A and/orstorage system 222B. Moreover, in accordance with aspects of theinvention, the program control 244 may communicate with a managementmodule 250, tracking module 260, the reading apparatus 102, and or otherremote devices 270 such as an operator's personal computer or mobiledevice. The management module 250 and tracking module 260 can beimplemented as one or more program code in the program control 244stored in memory 222A as separate or combined modules. Additionally, themanagement module 250 and tracking module 260 may be implemented asseparate dedicated processors or a single or several processors toprovide the function of these modules. In embodiments, the managementmodule 250 and tracking module 260 may be configured to carry out theprocesses of the present invention discussed in further detail herein.While executing the computer program code, the processor 220 can readand/or write data to/from memory 222A, storage system 222B, and/or I/Ointerface 224. The program code executes the processes of the invention.The bus 226 provides a communications link between each of thecomponents in the computing device 214.

The computing device 214 can comprise any general purpose computingarticle of manufacture capable of executing computer program codeinstalled thereon (e.g., a personal computer, a smartphone, a laptop, atablet, etc.). However, it is understood that computing device 214 isonly representative of various possible equivalent-computing devicesthat may perform the processes described herein. To this extent, in someembodiments, the functionality provided by computing device 214 can beimplemented by a computing article of manufacture that includes anycombination of general and/or specific purpose hardware and/or computerprogram code. In each embodiment, the program code and hardware can becreated using standard programming and engineering techniques,respectively.

Similarly, computing infrastructure 212 is only illustrative of varioustypes of computer infrastructures for implementing the invention. Forexample, in embodiments, server 212 comprises two or more computingdevices (e.g., a server cluster) that communicate over any type ofcommunications link, such as a network, a shared memory, or the like, toperform the process described herein. Further, while performing theprocesses described herein, one or more computing devices on server 212can communicate with one or more other computing devices external toserver 212 using any type of communications link. The communicationslink can comprise any combination of wired and/or wireless links; anycombination of one or more types of networks (e.g., the Internet, a widearea network, a local area network, a virtual private network, etc.);and/or utilize any combination of transmission techniques and protocols.

Instrument and Cartridge Quality Control Systems

Quality control testing of reagents for laboratory instrumentation hasconventionally been performed in the hospital laboratory by skilledtechnicians. In this model, a technician manually runs a new set ofreagents on a given instrument and checks the results to determine ifthey fall within the expected ranges for a set of control fluids. Whereaberrant results are obtained the technician can then check to see ifthe instrument is at fault, or whether the reagent formulation or assayprocedure is the root cause. The skill and experience of the techniciangenerally allows resolution of the problem. In this centralizedlaboratory model, the skilled technicians and all of the test equipmentare located together in a single laboratory and the responsibility ofthe point-of-care user (phlebotomist, nurse, or physician) is only todraw the blood sample, label it with the correct patient identifier andsend it to the laboratory. Essentially all other aspects of the qualitysystem associated with the sample analysis step are laboratory based.

By contrast, the implementation of point-of-care testing systems remotefrom the hospital laboratory and often remote from the discerningjudgment of skilled technical staff creates a novel technical problemfor quality assurance of blood testing reagents and devices.Particularly complex single-use integrated devices that contain sensors,reagents, and calibration and/or wash fluids present several issues.Here a robust quality control system and methodology that is efficientand simple to implement by staff not necessarily trained in laboratorymethods, e.g. nurses, nurse practitioners and other support staff, isadvantageous. Importantly, this should be done while still achieving thesame level of quality as in the hospital laboratory. The aforementionedtechnical solution for centrally managing and implementing a program forquality control compliance achieves these objectives.

A preferred embodiment comprises a method of determining qualitycompliance for a set of biological sample testing devices, e.g. severalhundred or thousands of cartridges of a single type and from a singlemanufacturing lot. As these may ultimately be used at many differentlocations throughout the hospital, e.g. Emergency Room and IntensiveCare Unit, and with multiple identical or different testing instruments,preferably a network of instruments, the quality control system andmethodology should be simple, robust and efficient.

It is standard practice that any given manufacturing lot of devices willhave a predetermined expiration date, set either by the manufacturer orthe hospital. In the present systems and methods, one or more cartridgesare tested using at least one control fluid on a given test instrument.Here the number of cartridges tested and the number and type of controlfluids is determined by a (computing device executed) data manager. Insome embodiments, the test instrument automatically communicates thequality control cartridge test data to the data manager. The datamanager is pre-programmed with an anticipated range of reported targetvalues for each of the control materials, and the data managerdetermines compliance of the recorded quality control test data withthese target values. The data manager then communicates with not onlythe test instrument from which the results were reported, but thenetwork of identical instruments in the hospital. The communicatedmessage is essentially binary, permitting use before the predeterminedexpiration date, of the given manufacturing lot of cartridges with anyof the instruments in the network when the cartridge test values are incompliance. However, if the results are not in compliance, then the datamanager locks out use of these cartridges on the entire network ofinstruments. Such a method enables multiple different types of testdevices from varying manufacturing lots to be efficiently managed in asimple manner compatible with delivery of accurate and timely results atthe point-of-care. In preferred embodiments, the communication betweenthe instruments and the data manager is by wireless means, e.g., a WiFicommunication protocol.

In another embodiment the systems and methods also comprise obtaining aninstrument configuration profile associated with the set of cartridgesfor a test instrument from a (computing device executed) configurationmanager which is part of the data manager. The same general procedure asdescribe above occurs, but with a specific configuration profile for thecartridge manufacturing lot, cartridge type, or both. Examples ofdifferent configurations include sensor coefficients, calibrant fluidanalyte values, and sensor response range limits, e.g., anticipatedcalibrant potential response windows for potentiometric sensors, andanticipated maximum and minimum calibration currents for amperometricsensors, and cell constants for conductimetric sensors.

In another embodiment, it is not necessary that the test instrument bepart of a network of instruments, but can operate as a stand-alonesystem, for example as a single unit at a doctor's office, a nursinghome, forward military medical support unit, and ambulance. Again aconfiguration compliance profile associated with the set of cartridgesfor the test instrument is obtained from a (computing device executed)configuration manager, e.g., by WiFi. As described previously, the stepof performing one or more cartridge tests using at least one controlfluid with the instrument is performed and the instrument determinescompliance of the test results with test target values based on theinstrument configuration profile. Where necessary, the instrument canlock out use of the set of cartridges if the cartridges are not incompliance.

In another embodiment, the systems and methods are illustrated as aseries of steps, specifically performing a quality control function fora plurality of wirelessly interconnected blood testing instruments whereeach instrument can test blood with a plurality of different cartridgetypes and is interconnected by a data manager. Firstly, receiving a setof cartridges, with a predetermined expiration date, of a single typefor use by one or more blood testing instruments. Secondly, performingone or more cartridge tests using at least one control fluid on aselected instrument, or a subset of instruments e.g. three out of anetwork of twenty or more instruments, where the number or cartridgestested and the number and type of control fluids is determined,scheduled and communicated by the data manager. For example, theselected instrument can in fact comprises two to five instruments as asubset of a network of instruments where the network of instruments isgreater than ten instruments. Thirdly, sending the quality controlcartridge test data from said instrument to the data manager, whereinthe data manager determines compliance of the data with one or moretarget values. Fourthly, the data manager communicates with theplurality of instruments, permitting use, before the predeterminedexpiration date, of the set of cartridges with any connected instrumentwhen the set of cartridges are in compliance and not permitting (lockingout) use of the set of cartridges with any connected instrument when theset of cartridges are not in compliance.

Those skilled in the art will recognize that it is not only thecartridges that need to be qualified (calibration verification). Otheraspects of the present invention are directed to ensuring instrumentsare qualified independently of the cartridges via the data manager. Inanother embodiment, this involves a method of performing calibrationverification for each of a plurality of wirelessly interconnected bloodtesting instruments where each instrument can test blood with aplurality of different cartridge types. Typically each instrument isinterconnected by the data manager, and the method further involvessignaling from the data manager to a selected instrument a requirementfor instrument calibration verification. This requires using one or moreselected known compliant blood test cartridges with one or more selectedcontrol fluids or an electronic simulator. Optionally, this informationis displayed as a prompt (with instructions) for the user on theinstrument display. Once the user has performed the indicated testing,in some embodiments the instrument communicates the instrumentcalibration verification test data to the data manager. Thereafter, thedata manager, or optionally the instrument, determines compliance of thedata with one or more target value, and then communicates with theinstrument, permitting use (for a predetermined time period) of theinstrument when the calibration verification is in compliance and notpermitting (locking out) use of the instrument when the calibrationverification is not in compliance.

In preferred embodiments, the data manager schedules the calibrationverification for each instrument that is interconnected, e.g. a networkof instruments, and optionally provides a replacement or maintenance foran instrument when the calibration verification is not in compliance.The schedule is generally set within an IQCP to be in compliance with agiven mandate from a state or country's regulatory body governinglaboratory medicine, e.g., CLIA.

FIG. 4 shows a high level architecture of an exemplary quality controlsystem 300 in accordance with the embodiments of the present invention.The quality control system 300 is configured to ensure that test devicesand/or test instruments of a biological sample testing system (e.g.,system 100 as discussed with respect to FIG. 1) that are non-compliantwith a quality control program are locked out from use on patientsamples. The quality control system 300 may be conceived for distributedor point of care analytical testing with a plurality of portable testinstruments 305 (e.g., sample testing instrument or reading apparatus102 as discussed with respect to FIG. 1), typically located in a medicalfacility. The sample testing instruments 305 are configured to receiveone or more devices 310 (e.g., devices 103 or cartridge 120 as discussedwith respect to FIGS. 1 and 2, respectively) for purposes of performingone or more analytical tests on a biological sample. Additionally, inaccordance with aspects of the present invention, the sample testinginstruments 305 are further configured to receive the one or moredevices 310 for purposes of performing one or more quality controlchecks and reporting quality control test data obtained from the qualitycontrol checks and quality control process data obtain from internalcontrol processes built into each of the sample testing instruments 305and the one or more devices 310 that are performed during performance ofthe one or more quality control checks.

In preferred embodiments, the sample testing instruments 305 arenetworked based on a client server model in which individual requestservices and resources from a centralized server such as a data manager315 (e.g., computing device 214 as discussed with respect to FIG. 3) arecommunicated over a network 320, such as a local area network, a widearea network, or a wireless device service provider (e.g., a cell phoneservice provider). In additional or alternative embodiments, the sampletesting instruments 305 are networked based on a peer-to-peer network inwhich interconnected nodes (the sample testing instruments 305) shareresources amongst one without the use of a centralized administrativesystem. The peer-to-peer network may be implemented with a virtualoverlay network on top of the network 320, where the nodes in theoverlay form a subset of the nodes in the network 320. Data is exchangeddirectly over the network 320, but at the application layer the nodesare able to communicate with each other directly via logical overlaylinks each of which corresponds to a path through the network 320.

In accordance with aspects of the client server model, the data manager315 comprises a configuration manager 325 (e.g., management module 250as discussed with respect to FIG. 3) and a data tracking system 330 withan operator tracking record 335 (e.g., tracking module 260 as discussedwith respect to FIG. 3). The data manager 315 is configured tocommunicate with and manage the network of sample testing instruments305 via the network 320. In order to manage the network of sampletesting instruments 305, the data manager 315 may be configured toobtain configuration profiles for sample testing instruments 305 anddevices 310, distribute attributes for quality control to the sampletesting instruments 305 based on one or more IQCPs and/or signal one ormore sample testing instruments 305 a requirement for instrumentcalibration or quality control verification based on one or more IQCPs,receive quality control test data and quality control process data fromone or more sample testing instruments 305, determine compliancestatuses of the sample testing instruments 305 and devices 310, storethe compliance statuses, and distribute the compliance statuses to thesample testing instruments 305.

In preferred embodiments, the configuration manager 325 is configured todevelop, modify, implement, and/or monitor one or more quality controlprograms, e.g., one or more IQCPs. Each type of device 310 (the types ofdevices are defined by the target analytes that are available fordetection using each type of device, e.g., a Chem 8+, Crea, E3+, etc.)may have a specific IQCP because each device is different and presentsunique risks. However, a single IQCP could cover multiple testsconducted with the same type of device 310 provided the IQCP factors inthe differences unique to each analyte. Each IQCP may be developed bylaboratory personnel and/or an administrator in conjunction with theconfiguration manager 325, or the configuration manager 325 can beconfigured to automatically select a preloaded IQCP dependent on certainparameters such as a type of device 310 being implemented within thepoint-of-care system. Development of each IQCP can be implemented viathe configuration manager 325 using templates, databases from othercomputing systems, e.g., LIS or HIS, schedulers, graphical userinterfaces, manufacturer's specifications, applicable regulatory andaccreditation requirements, and algorithms such as Westgard rules.

Development of the one or more IQCPs can be divided into four steps. Thefirst step involves collecting system information, includingmanufacturer recommendations on the proper use of devices or assays, themedical application of test results (how test results influence patientmanagement, are test results used for screening versus diagnosis) asthis will define performance specifications and allowable tolerancelimits for error, and applicable regulatory and accreditationrequirements. The second step involves failure modes and effectsanalysis, which identifies potential sources of failure and determineshow such failures affect the point-of-care system. All constituents ofthe point-of-care system, starting with the patient sample, reagents,environmental conditions that could affect the instruments 305 and thedevices 310, the instruments 305 and the devices 310 themselves, and thetesting personnel, are considered in the evaluation of possiblefailures. An estimate of the occurrence of these failures, whetherfrequent, occasional or remote, as well as the likelihood of harmarising from each failure is determined. The combination of frequencyand severity of harm may allow the configuration manager 325 to estimatethe criticality or risk of the error.

The third step includes selecting appropriate control measures to detector prevent the errors, and maintain risk at a clinically acceptablelevel based on the estimate of the criticality or risk of the error. Forexample, a common way to monitor the stability of a point-of-care systemis through the use of liquid quality control material. The configurationmanager 325 can be used to establish ranges and control rules thatdefine how much change in assay performance is allowed before thequality control data are considered out-of-control. Westgard rules areone such example that employ limits calculated from the mean value andstandard deviation of control samples measured when the system isstable, and describe when to accept or reject quality control data. Insome embodiments, a minimum of two levels of quality control each day oftesting may be used. However, the frequency of quality control testingshould reflect the point-of-care system risk and be based on thestability of the analyte and the point-of-care system, the presence ofbuilt-in controls, the number of patient samples processed, the clinicaluse of the test results and the frequency of calibration. The frequencyof quality control testing should also conform to regulatory andaccreditation requirements.

Measurement of quality control samples may be useful in detectingsystematic errors that affect all test results in a predictable manner.For example, liquid quality control is effective at detecting errorscaused by faulty operator technique (pipette errors or unacceptablemovement imparted on the instrument) that affect both patient andquality control samples in the same manner. However, liquid qualitycontrol does not address all potential failure modes. Random andunpredictable errors such as hemolysis or lipemia that affect individualsamples may be poorly detected by liquid quality control.

For this reason, aspects of the present invention may employ alternativequality control strategies, in addition to the liquid quality control,to ensure that the potential for high risk errors is covered. Forexample, the instruments 305 and the devices 310 incorporate a varietyof biologic and chemical controls and system electronic checksengineered into the test system to address a number of potential errors.Bubbles and clot detection can sense problems with specimen quality andalert the operator with an error code rather than a numerical testresult. Further, the devices 310 are consumed in the process ofanalyzing liquid quality control. Thus, liquid quality control provideslittle assurance that the next test will perform in the same manner.Such tests include built-in control lines or areas that can detectincorrect test performance and test mishandling or storage degradationwith each test. Accordingly, the IQCP may incorporate other controlprocesses that address the risk of errors that are most likely to affecttest results such as the quality of the specimen, the reactivity ofreagents such as polymerase enzyme, and the temperature cycling of theinstruments 305. The other control processes may include, withoutlimitation, programing to: detect specimen errors such as hemolysis,lipemia and icterus, significant differences between the current andprevious test results, detection of drift or shift in analyzerperformance over time, detection of expired devices 310, detection ofinstrument 305 orientation and movement, etc.

Once all of the weaknesses in the point-of-care system have beenidentified and appropriate control processes selected to address eachweakness, these hazards and control processes are summarized via theconfiguration manager 325 as the IQCP having a plurality of attributes.The IQCP is implemented by the data manager 315 using a configurationprofile comprising one or more attributes for each instrument 305 and/ordevice 310, and monitored for effectiveness to ensure that errors areadequately being detected and prevented. The IQCP can be monitored byreviewing quality benchmarks for each instrument 305 and/or device 310such as operator or physician complaints. When a complaint is received,the configuration manager 325 can be used to troubleshoot and determinewhat occurred and how to prevent recurrence of the error in the future.The IQCP should be reassessed to determine if this is a new failure notconsidered during development of the initial IQCP, or whether this is ahazard occurring at higher frequency or with greater severity of harmthan previously considered. Once risk is reassessed, the IQCP should beappropriately modified via the configuration manager 325 to maintainrisk to a clinically acceptable level, and the modified IQCP isimplemented.

In preferred embodiments, the development of the IQCP results in thecreation of the plurality of attributes, which are intended to ensurethat a right amount and type of quality control is implemented toaddress a laboratory's or medical care facility's specific risks andensure quality test results. The plurality of attributes for each IQCPmay be configured to identify internal and/or external quality controlsamples to be used for obtaining the quality control data, thresholds ortarget values for the control samples, the frequency of using thequality control samples, quality control rules, internal control processchecks, technical checks, administrative checks, and corrective actionto be taken as a result of invalid quality control data. The internalquality control samples identify control samples provided with devices310 that have a known reactivity. The external quality control samplesidentify control samples from an external source that has been validatedfor use with specific types of the devices 310 and have a knownreactivity. The thresholds or target values for the control samples areknown values for the reactivity of the control samples and may beprovided by the manufacturer of the devices 310 or a third party vendorproviding the control samples.

The control samples and corresponding thresholds or target values can beselected by the data manager 315 or a primary user. For example, thedata manager 315 can be configured to automatically select controlsamples and corresponding thresholds or target values based on controlsamples that ship with each manufacturing lot of devices 310 or controlsamples that are recommended by a manufacturer of the devices 310 forquality control of the devices 310. Optionally, the primary user can bea point-of-care coordinator who operates the data manager 315 tomanually select or input control samples and corresponding thresholds ortarget values based on similar information and/or additional informationsuch as information pertaining to external controls preferred by apoint-of-care facility. The thresholds or target values can be forincoming quality control, intermittent quality control, and/or dailyquality control. The thresholds or target values can be selected by thedata manager 315 or the primary user for each IQCP, each type of device310, each manufacturing lot of devices 310, each instrument 305 or asubset of instruments 305, etc.

The frequency of use can be defined based on temporal, process, orenvironmental conditions such as a minimum number of times per day, aminimum number of times per week and a preferred time of the week fortesting, upon a new shipment of devices 310, upon starting use of a newmanufacturer's lot number of devices 310, if environmental conditionsexceed a range for stability of devices 310, etc. Preferably, thequality control system 300 is designed with the data manager 315 havingthe functionality of a scheduler that accommodates IQCP based, devicetype based, lot based, and/or instrument based scheduling of performanceof quality control. For example, schedule requirements may becustomizable for each IQCP, cartridge type, manufacturer's lot,instrument, and/or subset of instruments. Specifically, the qualitycontrol fluids/levels to be run and the maximum period between qualitycontrol events may be defined, e.g., automatically using predefinedtemplates or in a selection menu. The lot-based feature accommodatesseparate requirements for initial lot acceptance (incoming qualitycontrol) and for scheduled (daily quality control) quality control. Thisfeature can also accommodate the recording of selected or predeterminedlot-acceptance information. Credit for passed quality control runs maybe shared with all instruments 305, and cartridge lot lockout could beconfigured to apply to all instruments 305 in the network. Generally, itmay be preferred that a specific instrument (or subset of instruments305) that is used for the quality control testing be changed from run torun, and thus such a feature could also be defined within the scheduler(e.g., an identifier for a given instrument or identifiers forinstruments within a subset of instruments can be included as anattribute for performing the quality control). Although, it is alsocontemplated by the present invention that a same or randomly selectedinstrument 305 or subset of instruments 305 may be used for all qualitycontrol testing.

The quality control rules are a decision criterion for judging whetheran analytical run is in-control or out-of-control, e.g., Westgard Rules,and may include utilizing one or more of the following: the thresholdsor target values for the control samples, the mean or average of qualitycontrol data, the standard deviation for the quality control data, thecoefficient of variation, a standard deviation index, a median ofquality control data, a mode of quality control data, a range of qualitycontrol data, a normal or Gaussian distribution of the quality controldata, and Levy-Jennings Charts, to determine a compliance status of eachof the instruments 305 and each manufacturer's lot of devices 310. Forexample, in some embodiments the configuration manager 325 may beconfigured to plot the manufacturer quality control mean and standarddeviation at the beginning of a new lot, e.g., the thresholds or targetvalues for the control samples, update the mean and standard deviationvalues after accumulating minimum number of quality control points ofdata, determine flags or invalidity of quality control data when aquality control rule is violated and/or the thresholds or target valuesare exceeded, and generate exception or exclusion logs or reports suchas compliance status reports for each manufacture's lot of the devices310 or each instrument 305.

The internal control process checks may include checks for biologic andchemical controls and system electronic checks that may be used todetect incorrect test performance and test mishandling or storagedegradation. For example, the internal control process checks may beconfigured to check for specimen errors such as hemolysis, lipemia andicterus, significant differences between the current and previous testresults, detection of drift or shift in analyzer performance over time,detection of expired devices 310, detection of instrument 305orientation and movement, detection of bubbles or clots within thesample, etc. In preferred embodiments, the predetermined expiration dateof devices 310 can by selected by the data manager 315 or a primaryuser. For example, the data manager 315 can be configured toautomatically select a predetermined expiration date based oninformation provided by the manufacturer for each manufacturing lot ofdevices 310. Optionally, the primary user can be a point-of-carecoordinator who operates the data manager 315 to manually select orinput a predetermined expiration date based on similar informationand/or additional information such as information pertaining to shippingconditions that may have affected the predetermined expiration date. Insome embodiments, the predetermined expiration date may be a modifiedexpiration date based on environmental conditions that each device mayhave been exposed to such as refrigerated and/or ambient temperatureshelf life (see, e.g., U.S. Pat. No. 7,552,071, which is incorporateherein in its entirety). The expiration of the devices 310 based on thepredetermined expiration date and/or the modified expiration date can bedetermined by the instruments 305/devices 310 and reported to the datamanager 315 as a portion of the quality control process data.

The technical checks may include checks for correlation and deltachecks. For example, the technical checks may be configured to checkwhether the analytical results fall within one or more sets of actionranges or reference ranges, whether multiple analytical test resultscorrelate, whether the analytical test results correlate with clinicaldiagnosis, whether the analytical results fall outside of certainclinically significant limits or critical values, and whether theanalytical results are impossible or incompatible with normal ranges ofthe analytical test. In preferred embodiments, a calibrationverification (Cal Ver) technical feature includes auto pass/failfunctionality to a known quality control auto pass/fail feature, whichacts as part of an advanced quality control baseline for a given IQCP.For example, the Cal Ver may include delta drift and verificationmethodology (see, e.g., U.S. Pat. No. 5,112,455, which is incorporatedherein in its entirety).

In additional or alternative embodiments, customizable action ranges maybe implemented in accordance with aspects of the present invention.Unlike conventional systems, which only exhibit a single set of actionranges and a single set of reference ranges for a given analyte, thepresent invention extends the functionality of action ranges andreference ranges by providing multiple sets of ranges applicable todifferent sample types, patient ages, and genders as defined in theconfiguration profile developed and/or provided by the configurationmanager 325. For example, multiple (e.g., five) action ranges for someanalytes, e.g., creatinine, may be defined in the configuration profilewhere the ranges are based on patient age. It is well established thatseveral analytes that are commonly measured in blood have differentreference ranges for various sub-populations, for example those based onage, gender and race.

The administrative checks may include checks for reporting results,checks for flagging of abnormal results, checks for test completion, andchecks for quality control and maintenance record upkeep. In preferredembodiments, customized critical results and/or critical tests may bedesignated and reported in accordance with attributes of the IQCP. Asdescribed herein, a critical result and/or critical test is a resultand/or test that always requires rapid communication of the results tothe user, e.g., physician. In the instance of a critical result, theresults are rapidly communicated as critical if within a specifiedcritical range, whereas in the instance of a critical test, the resultsare rapidly communicated independent of whether the results are normalor abnormal. In the traditional central laboratory model, the laboratorymanager is responsible for ensuring identified critical results andtests are reported within a certain time period. The attributes of thepresent invention may be configured to define an acceptable length oftime between the ordering of a test or critical test and the receipt ofthat the critical result or result of the critical test by theresponsible licensed caregiver. Additionally, where cartridge lots arein quality control compliance, any test run on the system permits usersto designate that specific test as a “critical test” to assure immediatenotification of licensed responsible caregiver for all results, via theinstrument display or across the network of instruments 305. The datamanager is 315 is also configured to check on whether the reporting anddesignation of critical results and tests are implemented in accordancewith the attributes defined for a given IQCP. The present invention alsoallows the data manager 315 to define attributes that identify criticalresults and tests based on a location in which the analytical test isperformed within the point-of-care facility. For example, the datamanager 315 can be used to define attributes that identify criticalresults and tests that are not specific or independent of the locationin which they are performed, or a specific or dependent of the locationin which they are performed, e.g., critical care but not the emergencyroom.

In additional or alternative embodiments, the critical results orresults of critical tests may be displayed on one or more instruments305 using graphical features, e.g., colored borders and icons adjacentto a given result on the instrument display. This feature acts toprovide a mechanism to capture a complete electronic record of criticalresult and test notifications and log the notifications on the datamanager 315 (e.g., saved with data store 340) for future reference aspart of the overall quality control system. This feature also ensuresthat regulatory requirements for reporting are met with minimal burdenfor operators and compliance risk for point-of-care testing is reducedfor the point-of-care facility. For example, the logging the criticalresult or test notifications provides a facility-customizable electronicform to all test records that contain critical result or critical test.The electronic form can be customized to include additional data (beyondthe standard test record elements) to ensure that a complete record ofphysician notification is captured, e.g., responsible caregiver, time ofnotification, etc. The electronic form may include specified fields inthe post-result accessible as pages from the data manager 315 and,optionally, on the display screen of individual instruments 305.Additional optional administrative check features include, auto-ordercapture, auto-prompt for notification, integrated timers/warnings, trackperformance metrics, user competency tracking and de-certification,notification of other users of non-compliance and electronicnotification and confirmation, etc.

The corrective action to be taken as a result of invalid quality controldata may include repeating the quality control test(s), assumption of aproblem with the instrument 305, the devices 310, the internal/externalcontrol samples, or an operator of the instrument 305, disabling theinstrument 305 from performing further analytical testing, which may bedevice 310 dependent or independent, continuation of analytical testingwith an alternative testing algorithm, diagnosing and identifying thecause of the problem, requesting maintenance or replacement of theinstrument 305, reporting problems to supervisory personnel oradministrators of the point-of-care quality control system, identifyingprocedures to take corrective action, etc. In preferred embodiments, amanufacturer's lot based quality control and corrective action approachmay be established such that a manufacturer's lot for a type of deviceis locked out from all instruments 305 within the network if the qualitycontrol attributes of the IQCP for the type of device 310 are not met ornon-compliant, e.g., quality control tests are not performed inaccordance with a defined schedule, quality control data is not withinthresholds or target values identified or set for control samples,quality control data fails one or more quality control checks, qualitycontrol process data does not satisfy one or more internal processcontrol checks, technical checks, or administrative checks, etc.

In preferred embodiments, the data tracking system 330 includes anoperator tracking record 335 (e.g., tracking module 260 as discussedwith respect to FIG. 3) and may be in communication with the data store340 (e.g., one or more databases stored in a memory such as storagesystem 222B or memory 222A as discussed with respect to FIG. 3).Additionally, the data tracking system can communicate in amono-directional or bi-directional manner with devices internal to thesystem 300 including the instruments 305, HIS 345, and LIS 350, andother devices 355 external to the system 300 (e.g., external computingdevices that could send data to the data tracking system 330, such as apersonal computing device or terminal within a facility). Operatorinformation for each instrument 305 may be maintained and stored withinthe operator tracking record 355 and/or the data store 340. The operatorinformation may include the identification of operators authorized toperform analytical tests within the point-of-care system usinginstruments 305 and devices 310, the identification of operators whoperformed quality control tests, the classification of operators aseither compliant or non-compliant with present competency testing forinstruments 305 and/or devices 310, and the identification of operatorsthat performed operations or analytical testing on each instrument 305.

The plurality of attributes for each IQCP (e.g., internal and/orexternal quality control samples, thresholds or target values for thecontrol samples, the frequency of using the quality control samples,quality control rules, etc.) may be stored in the data store 340. One ormore of the attributes (e.g., the identification of internal and/orexternal quality control samples, the thresholds or target values forthe control samples, and the frequency of using the quality controlsamples) for each IQCP may be selected by the data manager 315 or anadministrator such as quality compliance manager to generate theconfiguration profile, which is communicated from the data trackingsystem 330 to the instruments 305 to initiate compliance with a givenIQCP. Subsequently, quality control data and quality control processdata generated in response to the one or more attributes may becommunicated from the instruments 305 to the configuration manager 325and/or the data tracking system 330. The quality control data andquality control process data can be stored in the data store 340. Incircumstances of compliance with the IQCP, the data manager 315 maypermit use of at least one of the instruments 305 and/or use of at leastone device 310 with the instruments 305, whereas non-compliance mayautomatically lock out use on at least one of the instruments 305 and/oruse of at least one device 310 with the instruments 305. The complianceor non-compliance status of each instrument 305 and/or each device 310may be stored in the data store 340.

In preferred embodiments, the configuration manager 325 is configured togenerate an instrument configuration profile associated with a set ofdevices 310 (e.g., a manufacturing lot of devices), and after runningselect control samples, the quality control data is communicated to thedata manager 315 and the data manager 315 determines compliance of thequality control data with the thresholds or target values for thecontrol samples in the instrument configuration profile. The datamanager 315 then communicates with not only the test instrument 305 fromwhich the quality control data were communicated, but the network ofinstruments 305. The communicated message permits use before thepredetermined expiration date, of the set of devices 310 with any of theinstruments 305 in the network when the quality control data is incompliance. However, if the quality control data is not in compliance,then the message locks out use of the set of devices 310 on the entirenetwork of instruments 305.

Alternatively, the configuration manager 325 is configured to provide aninstrument configuration profile associated with a set of devices 310(e.g., a manufacturing lot of devices), and after running select controlsamples, the instrument 305 determines compliance of the quality controldata with the thresholds or target values for the control samples in theinstrument configuration profile. The instrument 305 then permits usebefore the predetermined expiration date, of the set of devices 310 withthe instruments 305 when the quality control data is in compliance.However, if the quality control data is not in compliance, then theinstrument 305 locks out use of the set of devices 310 on the instrument305. Additionally, the instrument 305 communicates with the network ofinstruments 305. The communicated message permits use before thepredetermined expiration date, of the set of devices 310 with any of theinstruments 305 in the network when the quality control data is incompliance. However, if the quality control data is not in compliance,then the message locks out use of the set of devices 310 on the entirenetwork of instruments 305.

Instrument and Cartridge Quality Control Methods

FIGS. 5-8 show exemplary flowcharts for performing the process steps ofthe present invention. The steps of FIGS. 5-8 may be implemented usingthe computing devices and systems described above with respect to FIGS.1-4. Specifically, the flowcharts in FIGS. 5-8 illustrate thearchitecture, functionality, and operation of possible implementationsof the systems, methods and computer program products according toseveral embodiments of the present invention. In this regard, each blockin the flowcharts may represent a module, segment, or portion of code,which comprises one or more executable instructions for implementing thespecified logical function(s). It should also be noted that, in somealternative implementations, the functions noted in the blocks may occurout of the order noted in the figure. For example, two blocks shown insuccession may, in fact, be executed substantially concurrently, or theblocks may sometimes be executed in the reverse order, depending uponthe functionality involved. It will also be noted that each block of theflowchart illustrations, and combinations of blocks in the flowchartillustrations, can be implemented by special purpose hardware-basedsystems that perform the specified functions or acts, or combinations ofspecial purpose hardware and computer instructions.

In one embodiment of the present invention, the computing devices andsystems described above may be configured to perform incoming,intermittent, and/or daily lot based quality control for one or moredevices in accordance with one or more IQCPs. As shown in FIG. 5, aprocess 500 may be provided for performing incoming, intermittent,and/or daily quality control for an nth lot/sublot of devices. At step505, an instrument configuration profile associated with the nthlot/sublot of devices (e.g., devices 310 as described with respect toFIG. 4) is communicated from a data manager (e.g., data manager 315 asdescribed with respect to FIG. 4) to one or more computing devices toinitiate the incoming, intermittent, and/or daily quality control of thenth lot/sublot of devices. In preferred embodiments, the instrumentconfiguration profile may be communicated from the data manager to atleast one of: all instruments (e.g., instruments 305 as described withrespect to FIG. 4) in a network, a defined instrument or subset ofinstruments in a network (e.g., defined via the attributes), a randomlyselected instrument or subset of instruments in a network, one or moreterminals of the HIS or LIS, and one or more external devices associatedwith users of the nth lot/sublot of devices. The instrumentconfiguration profile includes instructions on how to perform qualitycontrol in compliance with the one or more IQCPs. For example, theinstrument configuration profile may include the identification ofinternal and/or external quality control samples to be run on the nthlot/sublot of devices, the thresholds or target values for the controlsamples, and/or the frequency of performing the quality control.

At step 510, the instrument configuration profile is configured toinitiate procedures for performing the incoming, intermittent, and/ordaily quality control for the nth lot/sublot of devices. In preferredembodiments, the initiation procedure includes displaying a request forperformance of quality control on a display of the one or more computingdevices in accordance with the instrument configuration profile. Inadditional or alternative embodiments, the initiation procedure includesproviding an indicator for quality control such as a blinking lightemitting diode, displaying a graphical indicator on the display of theone or more computing devices, and/or sending a message to an operatorof the one or more computing devices such (e.g., an email or textmessage to an external device of the operator). In any event, theprocedures for performing the quality control may be triggered based onevents and/or a calendar as defined within the instrument configurationprofile. For example, a request for incoming quality control may betriggered upon receiving the nth lot/sublot of devices at a centrallaboratory from a manufacturer or receiving the nth lot/sublot ofdevices at a point-of-care location within a medical care facility.Alternatively, a request for intermittent quality control may betriggered upon powering on one or more instruments or intermittentlyselecting one or more instruments to perform the quality control.Alternatively, a request for daily quality control may be triggered uponinsertion of a device from the nth lot/sublot of devices into the one ormore instruments for the first time in a day or at a specified timewithin the day such as 8 am.

At step 515, the incoming, intermittent, and/or daily quality control isperformed for the nth lot/sublot of devices in accordance with theinstrument configuration profile. In preferred embodiments, theperformance of the incoming, intermittent, and/or daily quality controlincludes optionally determining an expiration date of the nth lot/sublotof devices (see, e.g., U.S. Patent Application Publication No.2013/0002279 and U.S. Pat. No. 7,552,071, which are incorporated hereinin their entireties) and/or performing one or more quality control testsby running one or more quality control samples defined within theinstrument configuration profile on one or more of the nth lot/sublot ofdevices in order to detect one or more target analytes within the one ormore quality control samples. The performance of the one or more qualitycontrol tests may be executed using the one or more instruments withinthe network as defined via the instrument configuration profile (e.g.,the one or more instruments to which the instrument configurationprofile was communicated). Alternatively, in instances in which theinstrument configuration profile does not define which of theinstruments to use for performing the one or more quality control test,then the one or more quality control tests may be performed on any ofthe instruments within the network capable of performing the qualitycontrol tests.

In additional or alternative embodiments, the performance of theincoming, intermittent, and/or daily quality control includes performingone or more tasks other than performing the quality control tests. Theperformance of the one or more tasks may be executed using the one ormore instruments (e.g., as defined by the instrument configurationprofile), the one or more terminals of the HIS or LIS, and/or the one ormore external devices. For example, the one or more IQCPs may bedeveloped to include attributes for incoming quality control thatinclude visual inspection tasks of the nth lot/sublot of devices such asvisually inspecting the number of the nth lot/sublot of devicesreceived, visually inspecting the integrity of the nth lot/sublot ofdevices (e.g., is the packaging compromised such that the devices aredamaged or exposed), and visually inspecting the expiration date of thenth lot/sublot of devices. Upon the visual inspection, the results ofthe visual inspection may be evaluated and recorded using the one ormore instruments, the one or more terminals of the HIS or LIS, and/orthe one or more external devices.

Optionally at step 520, quality control data, and optionally qualitycontrol process data, obtained from the performance of the incoming,intermittent, and/or daily quality control is communicated to the datamanager. The quality control data includes the results of the incoming,intermittent, and/or daily quality control performed using the one ormore instruments, the one or more terminals of the HIS or LIS, and/orthe one or more external devices such as an expiration date of the nthlot/sublot of devices, the quality control test results, and the resultsof the visual inspection the nth lot/sublot of devices. The qualitycontrol process data includes results from a variety of biologic andchemical controls and system electronic checks engineered into theinstruments and/or the devices to address a number of potential errors,e.g., the determination of bubbles in a quality control sample.

At step 525, the quality control data, and optionally the qualitycontrol process data, is evaluated to determine a compliance status ofthe nth lot/sublot of devices with the plurality of attributes of theIQCP. For example, the evaluation may include comparing the qualitycontrol test results with the thresholds or target values for thecontrol samples, and optionally control rules such as Westgard Rules,comparing a predetermined expiration date or a modified expiration datewith a current date, comparing a number of the nth lot/sublot of devicesreceived with a number of the nth lot/sublot of devices ordered oranticipated in the delivery, comparing a number of packages of the nthlot/sublot of devices that are damaged to an acceptable amount ofdamaged packages, and comparing temporal, process, and/or environmentalconditions to a schedule or acceptable conditions. If it is determinedthat the quality control data, and optionally the quality controlprocess data, comply with the attributes of the configuration profileand/or the IQCP, then the status of the nth lot/sublot of devices isrecorded as compliant. For example, in an instance where the qualitycontrol test results are within the thresholds or target values for thecontrol samples and the nth lot/sublot of devices are not expired, thenthe status of the nth lot/sublot of devices may be recorded to indicatea compliant status. However, if it is determined that the qualitycontrol data, and optionally the quality control process data, do notcomply with the plurality of attributes of the IQCP, then the status ofthe nth lot/sublot of devices is recorded as non-compliant. For example,in an instance where the quality control test results are outside thethresholds or target values for the control samples and the nthlot/sublot of devices are not expired, then the status of the nthlot/sublot of devices may be recorded to indicate a non-compliantstatus. Alternatively, in an instance where the quality control testresults are within the thresholds or target values for the controlsamples but the nth lot/sublot of devices are expired, then the statusof the nth lot/sublot of devices may be updated to indicate anon-compliant status.

In preferred embodiments, the quality control data, and optionallyquality control process data, is communicated to the data manager atstep 520 and the data manager evaluates the quality control data, andoptionally quality control process data to determine the compliancestatus of the nth lot/sublot of devices with the plurality of attributesof the IQCP. In alternative or additional embodiments, the one or moreinstruments that performed the incoming, intermittent, and/or dailyquality control evaluates the quality control data, and optionallyquality control process data to determine the compliance status of thenth lot/sublot of devices with the plurality of attributes of the IQCP.

As should be understood, the determination of the compliance statuscould be, but need not be, an all or nothing evaluation where anon-compliance status is determined whenever there is non-compliancewith at least one of the plurality of attributes. Instead, compliancewith the attributes can be evaluated holistically by the data manager,the instrument, and/or a user, e.g., an administrator, to make a finaldetermination on whether the nth lot/sublot of devices should receive acompliant or non-compliant status. For example, in an instance where thequality control test results are within the thresholds or target valuesfor the control samples and the nth lot/sublot of devices are notexpired but the number of the nth lot/sublot of devices received doesnot match the number of the nth lot/sublot of devices ordered oranticipated in the delivery, then a status of the nth lot/sublot ofdevices may be updated to indicate a compliant status regardless of theshortage or surplus of the nth lot/sublot of devices. Additionally, inan instance where the quality control test results are within thethresholds or target values for the control samples and the nthlot/sublot of devices are not expired but the nth lot/sublot of deviceswere delivered at ambient temperature rather than refrigeratedtemperature, then a status of the nth lot/sublot of devices may beupdated to indicate a compliant status regardless of the shippingenvironment conditions.

Furthermore it should be understood, the determination of the compliancestatus could be, but need not be, a definitive compliant ornon-compliant status. Instead, compliance or non-compliance with theattributes can be changed or updated by data manager, the instrument,and/or a user in view of corrective action and/or newly obtained qualitycontrol data, and optionally quality control process data. For example,in an instance where the quality control test results are outside thethresholds or target values for the control samples and the nthlot/sublot of devices are not expired but the quality control processdata indicates that bubbles were present during the quality controltest, then a status of the nth lot/sublot of devices may be updated toindicate a non-compliant status. However, the data manager, theinstrument, and/or a user may also be configured to implement correctiveaction as a result of the invalid quality control data such asrequesting the quality control test(s) be repeated while taking steps toalleviate bubble formation (e.g., reduce or prevent inappropriatemovement of the instrument during testing). Thereafter, if the qualitycontrol test results are now within the thresholds or target values forthe control samples and the nth lot/sublot of devices are not expired,then a status of the nth lot/sublot of devices may be updated toindicate a compliant status.

Although steps 515-525 are directed to instance in which the incoming,intermittent, and/or daily quality control is performed for the nthlot/sublot of devices, it should be understood that instances in whichthe incoming, intermittent, and/or daily quality control is notperformed are also contemplated by the present invention. For example,in instances in which the incoming, intermittent, and/or daily qualitycontrol is not performed in response to the instrument configurationprofile and/or the schedule of the incoming, intermittent, and/or dailyquality control, the data manager or the one or more instruments areconfigured to determine the compliance status of the nth lot/sublot ofdevices as non-compliant. The determination of non-compliant may bebased on the absence of the quality control data, and optionally thequality control process data, after a period of time in which it isexpected that the quality control data, and optionally the qualitycontrol process data, should have been generated and/or received inresponse to the instrument configuration profile and/or the schedule ofthe incoming, intermittent, and/or daily quality control.

At step 530, the determined compliance status of the nth lot/sublot ofdevices is recorded. In preferred embodiments, the determined compliancestatus of the nth lot/sublot of devices is recorded or stored in a datatable, e.g., a database, stored in memory of the data manager or the oneor more instruments that performed the incoming, intermittent, and/ordaily quality control. In additional or alternative embodiments, thedata table may be stored in a data table stored in data store, e.g.,data store 345 discussed with respect to FIG. 4, external to the datamanager or the one or more instruments. As should be understood by thoseof ordinary skill in the art, the data table may be configured toinclude any number and type of devices with corresponding lot numbersand compliance statuses beyond just the nth lot/sublot of devices suchthat the data table maintains a real time persistent record of thecompliance status of all devices available for use throughout apoint-of-care facility.

At step 535, the compliance status of the nth lot/sublot of devices iscommunicated to each instrument within the network of instruments. Inpreferred embodiments, the compliance status of the nth lot/sublot ofdevices is communicated to each instrument within the network ofinstruments from the data manager. In alternative or additionalembodiments, the compliance status of the nth lot/sublot of devices iscommunicated to each instrument within the network of instruments fromthe one or more instruments that performed the incoming, intermittent,and/or daily quality control (e.g., peer-to-peer). Thus, not only do theone or more instruments that performed the incoming, intermittent,and/or daily quality control know the compliance status of the nthlot/sublot of devices, but each instrument within the network ofinstruments knows the compliance status of the nth lot/sublot ofdevices.

The compliance status of the nth lot/sublot of devices is communicatedto each instrument by sending the data table as a part of the message ordata packet communicated to the instruments within the network. Once themessage or data packet is received by the instruments, the data tablewith the determined compliance status is stored in memory of theinstruments such that the instruments are continually capable ofobtaining the compliance status of all devices available for usethroughout a point-of-care facility.

In instances in which the compliance status of the nth lot/sublot ofdevices is non-compliant, the message communicated to the instrumentsmay further include corrective action that may be taken to possiblycorrect the failed quality control data. For example, the message mayinclude instructions to repeat the quality control tests, take apredetermined action such as placing the instrument on a solid surfaceduring testing, using a different set of control samples, perform apower cycle of the instrument, perform calibration of the instrument,etc. Additionally, in instances in which the compliance status of thenth lot/sublot of devices is non-compliant, an additional message may becommunicated from the data manager or the instrument to anothercomputing system or device, e.g., an external device such as aninventory control system, a computing terminal of the administrator orlaboratory personnel, and/or a computing device of maintenancepersonnel. The additional message may prompt or automatically triggerthe replacement of the nth lot/sublot of devices with another lot/sublotof devices either through an order being placed to the manufacturer orreplacement using internal inventory, as disclosed in, for example, U.S.Pat. No. 7,552,071. In some embodiments, the additional message mayalternatively or additionally prompt or automatically trigger a requestfor maintenance or replacement of the instrument. In accordance withaspects of the present invention, the corrective action and additionalmessages may be generated manually or triggered automatically inaccordance with the compliance or non-compliance of the quality controldata, and optionally the quality control process data, with theattributes of the configuration profile and/or the IQCP. For example,non-compliance with the expiration date of the nth lot/sublot of devicesmay prompt or trigger the replacement of the nth lot/sublot of deviceswhereas non-compliance with a proper thermal cycling of the instrumentcould be configured to prompt or trigger the request for maintenance orreplacement of the instrument.

At step 540, an instrument from the network of instruments obtainsinformation pertaining to one or more of the nth lot/sublot of devicesthat are intended to be used in conjunction with the instrument forperforming an analytical test on a patient sample and/or performinganother quality control test on one or more quality control samples. Forexample, the devices or boxes of the nth lot/sublot of devices includeone or more encoding arrangements configured to convey the informationto the instrument. More specifically, the various encoding arrangementsare configured to convey relevant information to the instrument, forexample, the identity of a specific device type, date and location ofmanufacture, manufacturing lot number, the predetermined or modifiedexpiration date, a unique number associated with a device, coefficientsfor use by the invention associated with the calculation of blood orother sample parameters and the like.

In preferred embodiments, the one or more encoding arrangements can bebased upon binary coding pin arrays of the types disclosed in, forexample, U.S. Pat. No. 4,954,087 and U.S. Provisional Patent ApplicationNo. 62/055,922, which are incorporated herein in their entireties. Forexample, the resistance of a resistor may be measured by a detector(e.g., processor) by applying a small voltage, e.g., 1 mV, between atleast two pins, subsequent to (e.g., immediately after) the device beinginserted into the instrument. The value of the measured resistance canthen be used by the instrument for cartridge and/or lot identification.For example, each cartridge type (e.g., i-STAT® cartridges EC8+, CG8+,EG7+, CHEM8+, etc.) and/or lot of cartridges may be associated with acertain resistance or resistance range such that a measured resistanceof the cartridge may be used to identify the type and/or lot of thecartridge using a look-up table.

In additional or alternative embodiments, the one or more encodingarrangements can be based upon a barcode such as a patient's bar-codedwristband, a barcode on the device, or from any other item such as a boxof the nth lot/sublot of devices, and either alternatively or inaddition to the barcode, a radio-frequency (RF) tag that is contained onor in each device or each box of devices, as disclosed in, for example,U.S. Pat. No. 7,552,071. For example, each device or box of devices canhave a code, such as for example, a bar code, RF tag, or the like,associated with the device or box of devices. When the device or box ofdevices are going to be used in conjunction with the instrument forperforming the analytical test or another quality control test, the codeassociated with the device or box of devices can be conveyed to theinstrument via an identification device associated with the instrument(e.g., via a barcode reader, an RF reader, or the like).

Optionally at step 545, the instrument from the network of instrumentsdetermines whether the one or more of the nth lot/sublot of devices areexpired. For example, the instrument may be configured to compare thepredetermined or modified expiration date obtained in step 540 to apresent time maintained or obtained via a processor within theinstrument to determine whether the predetermined or modified expirationdate has been elapsed. Additionally, or alternatively, the instrumentmay be configured to determine the expiration of the one or more of thenth lot/sublot of devices based on a time-temperature indicator such astime-temperature sensing circuitry, as disclosed in, for example, U.S.Pat. No. 7,552,071.

Optionally at step 550, when the one or more of the nth lot/sublot ofdevices are determined to be expired, the instrument is disabled fromperforming the analytical test and/or the another quality control test.For example, if an ambient or room temperature expiration date or timinghas elapsed, then the instrument locks out the expired devices. Becausethe expired devices are locked out, the expired devices are not used.Thus, exemplary embodiments of the present invention can prevent devicesfrom being used that have expired.

At step 555, when the one or more of the nth lot/sublot of devices aredetermined not to be expired, or in embodiments in which the instrumentdoes not perform step 545 to determine whether the one or more of thenth lot/sublot of devices are expired, the instrument from the networkof instruments obtains the determined compliance status of the one ormore of the nth lot/sublot of devices that are intended to be used inconjunction with the instrument for performing an analytical test and/oranother quality control test. For example, the instrument is configuredto use the information pertaining to the devices obtained in step 540 tolook up the compliance status of the devices in the data table stored instep 530.

At step 560, when the compliance status of the one or more of the nthlot/sublot of devices is compliant, the instrument is configured tooperate under normal operating procedures in order to perform theanalytical test and/or the another quality control test using the one ormore of the nth lot/sublot of devices. For example, insertion of the oneor more of the nth lot/sublot of devices into the instrument and theconfirmation of the compliant quality control compliance status executesprogram instructions that operate a mechanism such as a pump to applypressure to an air-bladder forcing air through one or more conduits ofthe one or more of the nth lot/sublot of devices to move a meteredportion of the patient sample or the quality control sample, that isoptionally amended with a compound or compounds present initially as adry coating on an inner surface of the one or more conduits, intocontact with an analyte sensor or sensors located within a detectionregion of the one or more conduits. Thereafter, electrical signalsgenerated from the detection of target analyte at the analyte sensor orsensors are transmitted from the one or more of the nth lot/sublot ofdevices to the instrument, where program instructions are executed tointerpret the electrical signals and provide, e.g., display and/orreport, a result(s) of the analytical test and/or the another qualitycontrol test.

At step 565, when the compliance status of the one or more of the nthlot/sublot of devices is non-compliant, the instrument is configured tobe at least partially disabled from performing the analytical testand/or the another quality control test. In accordance with aspects ofthe present invention, the at least partial disabling of the instrumentcan be implemented using a number of mechanisms and does not necessarilymean that the instrument does not operate and run the analytical testand/or the another quality control test. For example, in someembodiments, the instrument may be prevented from initiating performanceof the analytical test and/or the another quality control test using theone or more of the nth lot/sublot of devices such that the analyticaltest and/or the another quality control test are not run using theinserted device and the inserted device is not exhausted (i.e., theinstrument is completely disabled from performing the analytical testand/or the another quality control test). However, in preferredembodiments, the instrument may run the analytical test and/or theanother quality control test but instead of providing the results of theanalytical test and/or the another quality control test in accordancewith the normal operation of the instrument, the instrument isconfigured to provide, e.g., display and/or report, an error message,e.g., the lot number and/or type of device has failed quality control(i.e., the instrument is partially disabled from performing the one ormore analytical test). This mechanism would effectively preventreporting of the results to the operator and/or the health care team.

In alternative embodiments, if the compliance status of the device isnon-compliant, the instrument may be configured to run the one or moreanalytical tests and provide, e.g., display and/or report, the resultsof the one or more analytical tests. However, the display and/orreporting of the results includes a flag or some manner of indicatingthat the lot number and/or type of device has failed quality control.The flag may be configured to provide details on the failed qualitycontrol including the attributes of the IQCP that are not in compliance.In some embodiments, the details on the failed quality control may alsoinclude corrective action that may be taken to possibly correct thefailed quality control.

The advantage of the aforementioned technical solution for centrallymanaging and implementing IQCP for quality control compliance is that itwill eliminate the technical problems of having to perform a defaultfrequency of two levels of quality control each day on each unit-usetest device with liquid quality control and an inability to balance thedefault frequency of two levels of quality control with unit-use testdevices that include internal control systems and processes built intoeach unit-use test device. For example, implementation of the steps ofFIG. 5 using the computing devices and systems described above withrespect to FIGS. 1-4 provide a technical contribution over conventionalquality control systems and methods because the technical features ofthe present invention interoperate to enable or disable use of a set orlot of testing devices by some (e.g., a subset) or all of theinstruments in a network based on a plurality of attributes using acentralized computing environment to ensure quality across the networkof instruments and strike the right balance of liquid quality control inconcert with internal control processes.

In another embodiment of the present invention, the computing devicesand systems described above may be configured to perform periodicquality control for one or more instruments in accordance with one ormore IQCPs. It should be understood that although the incoming,intermittent, and/or daily quality control of the instruments issupported by the present invention using the following processes, itshould be understood that it may not be necessary to generate one ormore IQCPs that perform such quality control based on a risk managementapproach. As shown in FIG. 6, a process 600 may be provided forperforming incoming, intermittent, and/or daily quality control for oneor more particular instruments. At step 605, an instrument configurationprofile associated with the one or more instruments (e.g., instruments305 as described with respect to FIG. 4) is communicated from a datamanager (e.g., data manager 315 as described with respect to FIG. 4) tothe one or more instruments to initiate the incoming, intermittent,and/or daily quality control of the one or more instruments. Theinstrument configuration profile includes instructions on how to performquality control in compliance with the one or more IQCPs. For example,the instrument configuration profile may include the identification ofinternal and/or external quality control samples or calibrant samples tobe run on devices using the one or more instruments, the thresholds ortarget values for the control samples or calibrant samples, thefrequency of performing the quality control, and/or the identificationof one or more electronic simulations to be run using the one or moreinstruments.

At step 610, the instrument configuration profile is configured toinitiate procedures for performing the incoming, intermittent, and/ordaily quality control for the one or more instruments. In preferredembodiments, the initiation procedure includes displaying a request forperformance of quality control on a display of the one or moreinstruments in accordance with the instrument configuration profile. Inadditional or alternative embodiments, the initiation procedure includesproviding an indicator for quality control such as a blinking lightemitting diode, displaying a graphical indicator on the display of theone or more instruments, and/or sending a message to an operator of theone or more instruments (e.g., an email or text message to an externaldevice of the operator). In any event, the procedures for performing thequality control may be triggered based on events and/or a calendar asdefined within the instrument configuration profile. For example, arequest for intermittent or daily quality control may be triggered upona predetermined period of time elapsing. Alternatively, a request forintermittent quality control may be triggered upon an error messagebeing generated by the one or more instruments. Alternatively, a requestfor incoming quality control may be triggered upon use of the one ormore instruments for the first time in the point-of-care facility.

At step 615, the incoming, intermittent, and/or daily quality control isperformed for the one or more instruments in accordance with theinstrument configuration profile. In preferred embodiments, theperformance of the incoming, intermittent, and/or daily quality controlincludes performing one or more quality control tests by running one ormore quality control samples or calibration fluids defined within theinstrument configuration profile on devices in order to detect one ormore target analytes within the one or more quality control samples orcalibration fluids. The performance of the one or more quality controltests is executed using the particular one or more instruments withinthe network as defined via the instrument configuration profile (e.g.,the one or more instruments to which the instrument configurationprofile was communicated).

In additional or alternative embodiments, the performance of theincoming, intermittent, and/or daily quality control includes performingone or more electronic simulations defined within the instrumentconfiguration profile (i.e., controlled via the data manager) usinginternal program code and/or a reusable test unit that containscircuitry which provides electrical signals for testing instrumentfunction, as discussed for example in U.S. Pat. No. 5,124,661, which isincorporated herein in its entirety. The reusable test unit matesmechanically with the connector of the instrument to test both sides ofthe interface with the high-impedance electrochemical domain. Circuitrywithin the reusable test unit produces signals for testing amperometric,conductimetric, and potentiometric measurement channels, withoutconsuming any disposable sensor devices or requiring replenishment ofchemicals. In a preferred embodiment, power to the unit is suppliedthrough the connector from the instrument. Because the signals areproduced by electrical circuitry which simulates the operation ofchemical sensors, but does not employ actual sensors, no chemicals areused and no devices need be consumed for testing.

In additional or alternative embodiments, the performance of theincoming, intermittent, and/or daily quality control includes performingone or more tasks other than performing the quality control tests or oneor more electronic simulations. The performance of the one or more tasksmay be executed using the one or more instruments (e.g., as defined bythe instrument configuration profile), the one or more terminals of theHIS or LIS, and/or the one or more external devices. For example, theone or more IQCPs may be developed to include attributes for incomingquality control that include visual inspection tasks of the one or moreinstruments such as visually inspecting the one more instruments fordamage, functionality testing tasks such as testing connectivityfunctions with the network, and/or calibrating tasks such as calibratingthe thermistors of the one or more instruments. Upon completions of thetasks, the results of the tasks may be evaluated and recorded using theone or more instruments, the one or more terminals of the HIS or LIS,and/or the one or more external devices.

Optionally at step 620, quality control data, and optionally qualitycontrol process data, obtained from the performance of the incoming,intermittent, and/or daily quality control is communicated to the datamanager. The quality control data includes the results of the incoming,intermittent, and/or daily quality control performed using the one ormore instruments, the one or more terminals of the HIS or LIS, and/orthe one or more external devices such as the quality control testresults, the results of the electronic simulations, and/or the resultsof the visual inspection of the one or more instruments. The qualitycontrol process data includes results from a variety of biologic andchemical controls and system electronic checks engineered into theinstruments and/or the devices to address a number of potential errors,e.g., the determination of bubbles in a quality control sample.

At step 625, the quality control data, and optionally the qualitycontrol process data, is evaluated to determine a compliance status ofone or more instruments with the plurality of attributes of the IQCP.For example, the evaluation may include comparing the quality controltest results with the thresholds or target values for the controlsamples or calibration fluids, and optionally control rules such asWestgard Rules, comparing electronic simulation data to expectedsimulation data, comparing damage of the one or more instruments toacceptable damage criteria, and/or comparing temporal, process, and/orenvironmental conditions to a schedule or acceptable conditions. If itis determined that the quality control data, and optionally the qualitycontrol process data, comply with the attributes of the configurationprofile and/or the IQCP, then the status of the one or more instrumentsis recorded as compliant. For example, in an instance where the qualitycontrol test results are within the thresholds or target values for thecontrol samples or calibration fluids, or the electronic simulation datamatches expected simulation data, then the status of the one or moreinstruments may be recorded to indicate a compliant status. However, ifit is determined that the quality control data, and optionally thequality control process data, do not comply with the plurality ofattributes of the IQCP, then the status of the one or more instrumentsis recorded as non-compliant. For example, in an instance where thequality control test results are outside the thresholds or target valuesfor the control samples or calibration fluids, or the electronicsimulation data does not match expected simulation data, then the statusof one or more instruments may be recorded to indicate a non-compliantstatus.

In preferred embodiments, the quality control data, and optionallyquality control process data, is communicated to the data manager atstep 620 and the data manager evaluates the quality control data, andoptionally quality control process data to determine the compliancestatus of the one or more instruments with the plurality of attributesof the IQCP. In alternative or additional embodiments, the one or moreinstruments that performed the incoming, intermittent, and/or dailyquality control evaluates the quality control data, and optionallyquality control process data to determine the compliance status of theone or more instruments with the plurality of attributes of the IQCP.

As should be understood, the determination of the compliance statuscould be, but need not be, an all or nothing evaluation where anon-compliance status is determined whenever there is non-compliancewith at least one of the plurality of attributes. Instead, compliancewith the attributes can be evaluated holistically by the data manager,the instrument, and/or a user, e.g., an administrator, to make a finaldetermination on whether the one or more instruments should receive acompliant or non-compliant status. For example, in an instance where thequality control test results are within the thresholds or target valuesfor the control samples or calibration fluids, or the electronicsimulation data matches expected simulation data but the one or more ofthe instruments have damage such as a cracked display, then a status ofthe one or more of the instruments may be updated to indicate acompliant status regardless of the reported damage. Additionally, in aninstance where the quality control test results are within thethresholds or target values for the control samples or calibrationfluids, or the electronic simulation data matches expected simulationdata but the one or more of the instruments do not have connectivitywith the network, then a status of the one or more of the instrumentsmay be updated to indicate a compliant status regardless of theconnectivity issue.

Furthermore it should be understood, the determination of the compliancestatus could be, but need not be, a definitive compliant ornon-compliant status. Instead, compliance or non-compliance with theattributes can be changed or updated by data manager, the instrument,and/or a user in view of corrective action and/or newly obtained qualitycontrol data, and optionally quality control process data. For example,in an instance where the quality control test results are outside thethresholds or target values for the control samples or calibrationfluids but the quality control process data indicates that bubbles werepresent during the quality control test, then a status of the one ormore instruments may be updated to indicate a non-compliant status.However, the data manager, the instrument, and/or a user may also beconfigured to implement corrective action as a result of the invalidquality control data such as requesting the quality control test(s) berepeated while taking steps to alleviate bubble formation (e.g., reduceor prevent inappropriate movement of the instrument during testing).Thereafter, if the quality control test results are now within thethresholds or target values for the control samples or calibrationfluids, then a status of the one or more instruments may be updated toindicate a compliant status.

Although steps 615-625 are directed to instance in which the incoming,intermittent, and/or daily quality control is performed for the one ormore instruments, it should be understood that instances in which theincoming, intermittent, and/or daily quality control is not performedare also contemplated by the present invention. For example, ininstances in which the incoming, intermittent, and/or daily qualitycontrol is not performed in response to the instrument configurationprofile and/or the schedule of the incoming, intermittent, and/or dailyquality control, the data manager or the one or more instruments areconfigured to determine the compliance status of the one or moreinstruments as non-compliant. The determination of non-compliant may bebased on the absence of the quality control data, and optionally thequality control process data, after a period of time in which it isexpected that the quality control data, and optionally the qualitycontrol process data, should have been generated and/or received inresponse to the instrument configuration profile and/or the schedule ofthe incoming, intermittent, and/or daily quality control.

At step 630, the determined compliance status of the one or moreinstruments is recorded. In preferred embodiments, the determinedcompliance status of the one or more instruments is recorded or storedin a data table, e.g., a database, stored in memory of the data manageror the one or more instruments that performed the incoming,intermittent, and/or daily quality control. In additional or alternativeembodiments, the data table may be stored in a data table stored in datastore, e.g., data store 345 discussed with respect to FIG. 4, externalto the data manager or the one or more instruments. As should beunderstood by those of ordinary skill in the art, the data table may beconfigured to include any number of instruments with correspondingidentification numbers, for example a serial number or product number,and compliance statuses beyond just the one or more instruments suchthat the data table maintains a real time persistent record of thecompliance status of all instruments within the network and availablefor use throughout a point-of-care facility.

Optionally at step 635, in instances in which the quality control data,and optionally quality control process data, is communicated to the datamanager at step 620 and the data manager evaluates the quality controldata, the compliance status of the one or more instruments iscommunicated back to each of the one or instruments that communicatedwith the data manager. The compliance status of the one or moreinstruments is communicated to each instrument by sending the data tableas a part of the message or data packet communicated to the one or moreinstruments. Once the message or data packet is received by the one ormore instruments, the data table with the determined compliance statusis stored in memory of the one or more instruments such that each of oneor more instruments are continually capable of obtaining its compliancestatus, and optionally the compliance status of other instruments withinthe network.

In instances in which the compliance status of the one or moreinstruments is non-compliant, the message communicated to the one ormore instruments may further include corrective action that may be takento possibly correct the failed quality control data. For example, themessage may include instructions to repeat the quality control tests,take a predetermined action such as contacting a point of carecoordinator in the hospital, returning the instrument to a centralrepository and collecting a new instrument etc. Others may includeplacing the instrument on a solid surface during testing, using adifferent set of control samples or calibration fluids, perform a powercycle of the instrument, perform calibration of the instrument, etc.Additionally, in instances in which the compliance status of the one ormore instruments is non-compliant, an additional message may becommunicated from the data manager or the one or more instruments toanother computing system or device, e.g., an external device such as aninventory control system, a computing terminal of the administrator orlaboratory personnel, and/or a computing device of maintenancepersonnel. The additional message may prompt or automatically trigger arequest for maintenance or replacement of the one or more instruments.In accordance with aspects of the present invention, the correctiveaction and additional messages may be generated manually or triggeredautomatically in accordance with the compliance or non-compliance of thequality control data, and optionally the quality control process data,with the attributes of the configuration profile and/or the IQCP. Forexample, non-compliance due to quality control test results beingoutside the thresholds or target values for the control samples orcalibration fluids may prompt or trigger calibration of the one or moreinstruments whereas non-compliance with a proper thermal cycling of theone or more instruments could be configured to prompt or trigger therequest for maintenance or replacement of the instrument.

At step 640, each of the one or more instruments obtain their determinedcompliance status prior to performing an analytical test on a patientsample and/or performing another quality control test on one or morequality control samples or calibration fluids. For example, each of theone or more instruments are configured to use identification informationpertaining to the instrument, for example a serial number or productnumber, to look up the compliance status of the instrument in the datatable stored in step 630.

At step 645, when the compliance status of the instrument is compliant,the instrument is configured to operate under normal operatingprocedures in order to perform the analytical test and/or the anotherquality control test using one or more devices. For example, insertionof the one or more devices into the instrument and the confirmation ofthe compliant quality control compliance status executes programinstructions that operate a mechanism such as a pump to apply pressureto an air-bladder forcing air through one or more conduits of one ormore devices to move a metered portion of the patient sample, thequality control sample, or the calibration fluid, that is optionallyamended with a compound or compounds present initially as a dry coatingon an inner surface of the one or more conduits, into contact with ananalyte sensor or sensors located within a detection region of the oneor more conduits. Thereafter, electrical signals generated from thedetection of target analyte at the analyte sensor or sensors aretransmitted from the one or more devices to the instrument, whereprogram instructions are executed to interpret the electrical signalsand provide, e.g., display and/or report, a result(s) of the analyticaltest and/or the another quality control test.

At step 650, when the compliance status of instruments is non-compliant,the instrument is configured to be at least partially disabled fromperforming the analytical test and/or the another quality control test.In accordance with aspects of the present invention, the at leastpartial disabling of the instrument can be implemented using a number ofmechanisms and does not necessarily mean that the instrument does notoperate and run the analytical test and/or the another quality controltest. For example, in some embodiments, the instrument may be preventedfrom initiating performance of the analytical test and/or the anotherquality control test using the one or more devices such that theanalytical test and/or the another quality control test are not runusing the inserted device and the inserted device is not exhausted(i.e., the instrument is completely disabled from performing theanalytical test and/or the another quality control test). However, inpreferred embodiments, the instrument may run the analytical test and/orthe another quality control test but instead of providing the results ofthe analytical test and/or the another quality control test inaccordance with the normal operation of the instrument, the instrumentis configured to provide, e.g., display and/or report, an error message,e.g., the instrument has failed quality control (i.e., the instrument ispartially disabled from performing the one or more analytical test).This mechanism would effectively prevent reporting of the results to theoperator and/or the health care team.

In alternative embodiments, if the compliance status of the device isnon-compliant, the instrument may be configured to run the one or moreanalytical tests and provide, e.g., display and/or report, the resultsof the one or more analytical tests. However, the display and/orreporting of the results includes a flag or some manner of indicatingthat the instrument has failed quality control. The flag may beconfigured to provide details on the failed quality control includingthe attributes of the IQCP that are not in compliance. In someembodiments, the details on the failed quality control may also includecorrective action that may be taken to possibly correct the failedquality control.

The advantage of the aforementioned technical solution for centrallymanaging and implementing IQCP for quality control compliance is that itwill eliminate the technical problems of having to perform a defaultfrequency of quality control with liquid quality control or calibrationfluid and an inability to balance the default frequency with instrumentsthat include internal control systems and processes built into eachinstrument. For example, implementation of the steps of FIG. 6 using thecomputing devices and systems described above with respect to FIGS. 1-4provide a technical contribution over conventional quality controlsystems and methods because the technical features of the presentinvention interoperate to enable or disable use of each instruments in anetwork based on a plurality of attributes using a centralized computingenvironment to ensure quality across the network of instruments andstrike the right balance of liquid quality control or calibration fluidin concert with internal control processes.

In another embodiment of the present invention, the computing devicesand systems described above may be configured to develop and implementone or more IQCPs for performing incoming, intermittent, and/or dailylot based quality control for one or more devices. As shown in FIG. 7, aprocess 700 may be provided for developing and implementing one or moreIQCPs for performing incoming, intermittent, and/or daily qualitycontrol for an nth lot/sublot of devices. At step 705, a manufacturercreates an nth lot/sublot of devices (e.g., cartridges) and ships thenth lot/sublot of devices to a customer (e.g., a point-of-careprovider). The lot/sublot of devices are manufactured as identical orsubstantially identical products and identified using a numerical oralphanumeric lot/sublot identifier. At step 710, the a point-of-careprovider receives the nth lot/sublot of devices. For example, the apoint-of-care provider may scan the identification the nth lot/sublot ofdevices into one or more systems, e.g., the data manager, HIS, and/orLIS, and physically receive and store the nth lot/sublot of devices inan inventory such as a centrally refrigerated inventory. At step 715,the a point-of-care provider develops a new IQCP for the nth lot/sublotof devices or implements an existing IQCP for the nth lot/sublot ofdevices. The IQCP may be developed by laboratory personnel and/or anadministrator in conjunction with a configuration manager (e.g.,configuration manager 325 as described with respect to FIG. 4), or theconfiguration manager can be configured to automatically select apreloaded IQCP based on certain parameters such as a type of devicereceived or the nth lot/sublot identifier of the devices received, asdiscussed in detail with respect to FIG. 4. The IQCP is developed toinclude a plurality of attributes, which are intended to ensure that aright amount and type of quality control is implemented with respect tothe nth lot/sublot of devices to address the customer's specific risksand ensure quality test results.

At step 720, an instrument configuration profile associated with the nthlot/sublot of devices may be generated by the configuration managerusing one or more of the plurality attributes. In preferred embodiments,the instrument configuration profile includes instructions on how toperform quality control in compliance with the IQCP including theidentification of internal and/or external quality control samples to berun on the nth lot/sublot of devices, the thresholds or target valuesfor the control samples, and the frequency of using the quality controlsamples. Additionally, the instrument configuration profile is designedto initiate compliance with the IQCP. At step 725,

the instrument configuration profile may be communicated from the datamanager to all instruments in a network, a defined instrument or subsetof instruments in a network (e.g., defined via the attributes), or arandomly selected instrument or subset of instruments in a network.Thereafter, the instrument configuration profile may be configured toinitiate procedures for performing incoming, intermittent, and/or dailyquality control. In some embodiments, the procedure may includeprompting a display of a request for performance of quality control inaccordance with the instrument configuration profile on the one or moreinstruments in which the instrument configuration profile wascommunicated, on one or more terminals of the HIS or LIS, and/or on anexternal device associated with a user of the nth lot/sublot of devices.

At step 730, incoming quality control may be performed on the nthlot/sublot of devices in accordance with the instrument configurationprofile to determine a compliance status of the nth lot/sublot ofdevices. The incoming quality control and determination of thecompliance status is performed in a similar manner to that describedwith respect to steps 515-530 of FIG. 5. At step 735, the compliancestatus of the nth lot/sublot of devices is communicated to eachinstrument within the network of instruments in a similar manner to thatdescribed with respect to step 535 of FIG. 5. As should be understood,the compliance status of the nth lot/sublot of devices may becommunicated to each instrument from the one or more instruments (notshown) that performed and evaluated the quality control performed on thenth lot/sublot of devices, or from the data manager (shown) whichreceived and evaluated the results of the performance of the qualitycontrol by the one or more instruments.

At step 740, when the compliance status of the one or more of the nthlot/sublot of devices is non-compliant, the instrument is configured tobe at least partially disabled from performing analytical tests and/oranother quality control test in a similar manner to that described withrespect to step 565 of FIG. 5. Optionally at step 745, the one or moreof the nth lot/sublot of devices, which are non-compliant, may beshipped back by the point-of-care provider to the device provider asbeing defective. Optionally at step 750, the device provider may receivethe nth lot/sublot of devices.

At step 755, when the compliance status of the one or more of the nthlot/sublot of devices is compliant, the instrument is configured tooperate under normal operating procedures in order to perform analyticaltests and/or other quality control tests using the one or more of thenth lot/sublot of devices in a similar manner to that described withrespect to step 560 of FIG. 5. At step 760, the point-of-care providerdistributes the nth lot/sublot of devices to one or more point-of-carelocations, as disclosed in, for example, U.S. Pat. No. 7,552,071.

At step 765, one or more analytical test are performing using the one ormore devices from the nth lot/sublot of devices in a similar manner tothat described with respect to steps 540-565 of FIG. 5. At step 770,intermittent and/or daily quality control may be performed on the nthlot/sublot of devices in accordance with the instrument configurationprofile to determine a compliance status of the nth lot/sublot ofdevices. The intermittent and/or daily quality control and determinationof the compliance status is performed in a similar manner to thatdescribed with respect to steps 515-530 of FIG. 5. At step 775, thecompliance status of the nth lot/sublot of devices is communicated toeach instrument within the network of instruments in a similar manner tothat described with respect to step 535 of FIG. 5. As should beunderstood, the compliance status of the nth lot/sublot of devices maybe communicated to each instrument from the one or more instruments (notshown) that performed and evaluated the quality control performed on thenth lot/sublot of devices, or from the data manager (shown) whichreceived and evaluated the results of the performance of the qualitycontrol by the one or more instruments.

At step 780, when the compliance status of the one or more of the nthlot/sublot of devices is non-compliant, the instrument is configured tobe at least partially disabled from performing analytical tests and/oranother quality control test in a similar manner to that described withrespect to step 565 of FIG. 5. Optionally at step 785, the one or moreof the nth lot/sublot of devices, which are non-compliant, may bediscarded and/or replaced, as disclosed in, for example, U.S. Pat. No.7,552,071. At step 790, when the compliance status of the one or more ofthe nth lot/sublot of devices is compliant, the instrument is configuredto operate under normal operating procedures in order to performanalytical tests and/or other quality control tests using the one ormore of the nth lot/sublot of devices in a similar manner to thatdescribed with respect to step 560 of FIG. 5.

In another embodiment of the present invention, the computing devicesand systems described above may be configured to develop and implementone or more IQCPs for performing incoming, intermittent, and/or dailylot based quality control for one or more instruments. As shown in FIG.8, a process 800 may be provided for developing and implementing one ormore IQCPs for performing incoming, intermittent, and/or daily qualitycontrol for one or more instrument within a point-of-care network. Atstep 805, a customer such as a point-of-care provider implements one ormore instruments within a point-of-care network. For example, thecustomer may scan the identification the one or more instruments intoone or more systems, e.g., the data manager, HIS, and/or LIS, andphysically receive the one or more instruments in an inventory. At step810, the customer develops a new IQCP for the one or more instruments orimplements an existing IQCP for the one or more instruments. The IQCPmay be developed by laboratory personnel and/or an administrator inconjunction with a configuration manager (e.g., configuration manager325 as described with respect to FIG. 4), or the configuration managercan be configured to automatically select a preloaded IQCP based oncertain parameters such as a model of instrument received or theinstrument identifier of the instrument implemented, as discussed indetail with respect to FIG. 4. The IQCP is developed to include aplurality of attributes, which are intended to ensure that a rightamount and type of quality control is implemented with respect to theinstrument to address the customer's specific risks and ensure qualitytest results. It should be understood that although the incoming,intermittent, and/or daily quality control of the instruments issupported by the present invention using the following processes, itshould be understood that it may not be necessary to generate one ormore IQCPs that perform such quality control based on a risk managementapproach.

At step 815, an instrument configuration profile associated with the oneor more instruments may be generated by the configuration manager usingone or more of the plurality attributes. In preferred embodiments, theinstrument configuration profile includes instructions on how to performquality control in compliance with the IQCP including the identificationof internal and/or external quality control samples or calibrationfluids to be run on the one or more instruments, the thresholds ortarget values for the control samples or calibration fluids, and thefrequency of using the quality control samples or calibration fluids.Additionally, the instrument configuration profile is designed toinitiate compliance with the IQCP. At step 820, the instrumentconfiguration profile may be communicated from the data manager to allinstruments in a network, a defined instrument or subset of instrumentsin a network (e.g., defined via the attributes), or a randomly selectedinstrument or subset of instruments in a network. Thereafter, theinstrument configuration profile may be configured to initiateprocedures for performing the incoming, intermittent, and/or dailyquality control. In some embodiments, the procedure may includeprompting a display of a request for performance of quality control inaccordance with the instrument configuration profile on the one or moreinstruments in which the instrument configuration profile wascommunicated, on one or more terminals of the HIS or LIS, and/or on anexternal device associated with a user of the one or more instruments.

At step 825, incoming quality control may be performed on the one ormore instruments in accordance with the instrument configuration profileto determine a compliance status of one or more instruments. Theincoming quality control and determination of the compliance status isperformed in a similar manner to that described with respect to steps615-630 of FIG. 6. Optionally at step 830, in instances in which thequality control data, and optionally quality control process data, iscommunicated to the data manager at step 825 and the data managerevaluates the quality control data, the compliance status of the one ormore instruments is communicated back respectively to each of the one orinstruments in a similar manner to that described with respect to step635 of FIG. 6.

At step 835, when the compliance status of one or more instruments isnon-compliant, the one or more instruments are configured to be at leastpartially disabled from performing analytical tests and/or anotherquality control test in a similar manner to that described with respectto step 650 of FIG. 6. Optionally at step 840, a request may be issuedfor replacement or maintenance of the non-compliant one or moreinstruments in a similar manner to that described with respect to step635 of FIG. 6.

At step 845, when the compliance status of the one or more instrumentsis compliant, the one or more instruments are configured to operateunder normal operating procedures in order to perform analytical testsand/or other quality control tests using one or more devices in asimilar manner to that described with respect to step 645 of FIG. 6. Atstep 850, the point-of-care provider distributes the one or moreinstruments to one or more point-of-care locations.

At step 855, one or more analytical test are performing using the one ormore instruments in a similar manner to that described with respect tostep 645 of FIG. 6. At step 860, intermittent and/or daily qualitycontrol may be performed on the one or more instruments in accordancewith the instrument configuration profile to determine a compliancestatus of the one or more instruments. The intermittent and/or dailyquality control and determination of the compliance status is performedin a similar manner to that described with respect to steps 615-630 ofFIG. 6. Optionally at step 865, in instances in which the qualitycontrol data, and optionally quality control process data, iscommunicated to the data manager at step 855 and the data managerevaluates the quality control data, the compliance status of the one ormore instruments is communicated back respectively to each of the one orinstruments in a similar manner to that described with respect to step635 of FIG. 6.

At step 870, when the compliance status of the one or more instrumentsis compliant, the one or more instruments are configured to operateunder normal operating procedures in order to perform analytical testsand/or other quality control tests using one or more devices in asimilar manner to that described with respect to step 645 of FIG. 6. Atstep 875, when the compliance status of one or more instruments isnon-compliant, the one or more instruments are configured to be at leastpartially disabled from performing analytical tests and/or anotherquality control test in a similar manner to that described with respectto step 650 of FIG. 6. Optionally at step 880, a request may be issuedfor replacement or maintenance of the non-compliant one or moreinstruments in a similar manner to that described with respect to step635 of FIG. 6.

While the invention has been described in terms of various preferredembodiments, those skilled in the art will recognize that variousmodifications, substitutions, omissions and changes can be made withoutdeparting from the spirit of the present invention. It is intended thatthe scope of the present invention be limited solely by the scope of thefollowing claims. In addition, it should be appreciated by those skilledin the art that a plurality of the various embodiments of the invention,as described above, may be coupled with one another and incorporatedinto a single reader device.

We claim:
 1. A portable clinical analyzer for in vitro analysis, theanalyzer comprising: a port configured to receive a sample testingcartridge of a set of sample testing cartridges; and a computing deviceconfigured to: receive an instrument configuration profile associatedwith the portable clinical analyzer; in response to receiving theinstrument configuration profile, prompt a user to initiate proceduresfor performance of analyzer calibration verification in accordance withthe instrument configuration profile, wherein the instrumentconfiguration profile includes: (i) identification of a predeterminednumber and type of calibration fluids and a predetermined number ofsample testing cartridges of the set of sample testing cartridges to beused for the performance of the analyzer calibration verification, or(ii) identification of an electronic simulation to be used for theperformance of the analyzer calibration verification; control theportable clinical analyzer to perform the analyzer calibrationverification using: (i) the predetermined number and type of calibrationfluids and & the predetermined number of sample testing cartridges ofthe set of sample testing cartridges, or (ii) the electronic simulation,to generate calibration verification data; transmit the calibrationverification data to a data manager; receive a message from the datamanager, wherein the message includes a data table comprising: (i) anidentification number associated with each analyzer within a group ofanalyzers including the portable clinical analyzer, and (ii) acompliance status for each analyzer within the group of analyzersincluding the portable clinical analyzer, wherein the compliance statusis a binary determination of either compliant or non-compliant for eachanalyzer within the group of analyzers; storing the data table in memoryof the portable clinical analyzer such that the portable clinicalanalyzer is continually capable of obtaining the compliance status forthe portable clinical analyzer and other analyzers within the group ofanalyzers; obtaining the compliance status for the portable clinicalanalyzer from the data table stored in the memory of the portableclinical analyzer based on an identification number associated with theportable clinical analyzer; when the compliance status obtained from thedata table indicates the portable clinical analyzer is in compliance,enable use of the portable clinical analyzer for performing one or moreanalytical tests on biological samples; and when the compliance statusobtained from the data table indicates the portable clinical analyzer isnot in compliance, at least partially disable use of the portableclinical analyzer for performing the one or more analytical tests on thebiological samples.
 2. A system comprising: a set of sample testingcartridges; a plurality of analyzers in communication with one anothervia a wireless network, wherein each analyzer of the plurality ofanalyzers comprises a processor configured to: receive an instrumentconfiguration profile; in response to receiving the instrumentconfiguration profile, prompt a user to initiate procedures forperformance of analyzer calibration verification in accordance with theinstrument configuration profile, wherein the instrument configurationprofile includes: (i) identification of a predetermined number and typeof calibration fluids and a predetermined number of sample testingcartridges of the set of sample testing cartridges to be used for theperformance of the analyzer calibration verification, or (ii)identification of an electronic simulation to be used for theperformance of the analyzer calibration verification; control theanalyzer to perform the analyzer calibration verification using: (i) thepredetermined number and type of calibration fluids and thepredetermined number of sample testing cartridges of the set of sampletesting cartridges, or (ii) the electronic simulation, to generatecalibration verification data; and transmit the calibration verificationdata; a data manager that is in communication with each analyzer of theplurality of analyzers via the wireless network, wherein the datamanager is configured to: communicate the instrument configurationprofile to the plurality of analyzers; receive a first set of thecalibration verification data from a first analyzer of the plurality ofanalyzers; receive a second set of the calibration verification datafrom a second analyzer of the plurality of analyzers; determine a firstcompliance status of the first analyzer based on whether the first setof the calibration verification data is within range of predeterminedcalibration target values, wherein the first compliance status is abinary determination of either compliant or non-compliant; determine asecond compliance status of the second analyzer based on whether thesecond set of the calibration verification data is within range of thepredetermined calibration target values, wherein the second compliancestatus is a binary determination of either compliant or non-compliant;store the determined first compliance status of the first analyzer aseither compliant or non-compliant and the second compliance status ofthe second analyzer as either compliant or non-compliant in a datatable; communicate a first message to the first analyzer, wherein thefirst message includes the data table, and wherein when the firstcompliance status indicates the first analyzer is non-compliant, thefirst message further includes corrective action to be taken to correctthe first set of the calibration verification data; and communicate asecond message to the second analyzer, wherein the second messageincludes the data table, and wherein when the second compliance statusindicates the second analyzer is non-compliant, the second messagefurther includes corrective action to be taken to correct the second setof the calibration verification data, wherein a first processor of thefirst analyzer is configured to: receive the first message with at leastthe data table and store the data table in memory of the first analyzer;obtain the first compliance status for the first analyzer from the datatable stored in the memory of the first analyzer; when the firstcompliance status obtained from the data table indicates the firstanalyzer is compliant, enable use of the first analyzer for performingone or more analytical tests on biological samples; and when the firstcompliance status obtained from the data table indicates the firstanalyzer is non-compliant, at least partially disable use of the firstanalyzer for performing the one or more analytical tests on thebiological samples and provide the corrective action to be taken tocorrect the first set of calibration verification data; and wherein asecond processor of the second analyzer is configured to: receive thesecond message with at least the data table and store the data table inmemory of the second analyzer; obtain the second compliance status forthe second analyzer from the data table stored in the memory of thesecond analyzer; when the second compliance status obtained from thedata table indicates the second analyzer is compliant, enable use of thesecond analyzer for performing the one or more analytical tests onbiological samples; and when the second compliance status obtained fromthe data table indicates the second analyzer is non-compliant, at leastpartially disable use of the second analyzer for performing the one ormore analytical tests on the biological samples and provide thecorrective action to be taken to correct the second set of calibrationverification data.
 3. The system of claim 2, further comprising aconfiguration manager configured to obtain the predetermined calibrationtarget values, and transmit the instrument configuration profile withthe predetermined calibration target values to the data manager.
 4. Thesystem of claim 2, wherein the one or more analytical tests areconfigured to detect one or more analytes selected from the groupconsisting of: sodium, potassium, chloride, total carbon dioxide,ionized calcium, glucose, blood urea nitrogen (BUN), creatinine,lactate, hematocrit, pH, partial pressure of carbon dioxide, partialpressure of oxygen, troponin I, troponin T, creatine kinase MB,procalcitonin, beta human chorionic gonadotropin (bHCG), human chorionicgonadotropin (HCG), N-terminal of the prohormone brain natriureticpeptide (NTproBNP), prohormone brain natriuretic peptide (proBNP), brainnatriuretic peptide (BNP), myoglobin, parathyroid hormone, d-dimer,neutrophil gelatinase-associated lipocalin (NGAL), galectin-3, andprostate specific antigen (PSA).
 5. The system of claim 2, wherein thepredetermined number of calibration fluids is one to five.
 6. The systemof claim 2, wherein the predetermined number of the sample testingcartridges of the set of sample testing cartridges is one to five. 7.The system of claim 2, wherein the data manager is further configuredto: generate a schedule comprising a scheduled time for the analyzercalibration verification for each analyzer of the plurality ofanalyzers; and transmit the instrument configuration profile to eachanalyzer of the plurality of analyzers in accordance with the schedule.8. The system of claim 7, wherein the data manager is further configuredto reset a scheduled time for the analyzer calibration verification foreach analyzer of the plurality of analyzers that has a determinedcompliance status that indicates compliance.
 9. The system of claim 2,wherein the data manager is further configured to send a request for areplacement analyzer for each analyzer of the plurality of analyzersthat has a determined compliance status that indicates not incompliance.
 10. The system of claim 2, wherein the data manager isfurther configured to send a request for maintenance for each analyzerof the plurality of analyzers that has a determined compliance statusthat indicates not in compliance.
 11. The system of claim 2, wherein theprompting the user to initiate the procedures for the performance of theanalyzer calibration verification includes displaying a request for theperformance of the analyzer calibration verification on a display of ananalyzer in accordance with the instrument configuration profile. 12.The system of claim 2, wherein the identified electronic simulation isperformed by an electronic simulator configured to use mathematicalmodels to replicate behavior of a sample testing cartridge incommunication with an analyzer.
 13. The system of claim 12, wherein eachanalyzer of the plurality of analyzers further comprises the electronicsimulator.
 14. The system of claim 12, wherein the electronic simulatoris a separate computing device from the processor of each analyzer ofthe plurality of analyzers.
 15. A computer implemented methodcomprising: receiving, at an analyzer, an instrument configurationprofile associated with the analyzer, wherein the analyzer is part of agroup of analyzers in communication with one another via a wirelessnetwork; in response to receiving the instrument configuration profile,prompting, by the analyzer, a user to initiate procedures forperformance of analyzer calibration verification in accordance with theinstrument configuration profile, wherein the instrument configurationprofile includes: identification of a predetermined number and type ofcalibration fluids and a predetermined number of sample testingcartridges of a set of sample testing cartridges to be used for theperformance of the analyzer calibration verification; performing, by theanalyzer, one or more quality control tests to generate calibrationverification data, the one or more quality control tests being performedusing: (i) the predetermined number and type of calibration fluids, and(ii) the predetermined number of sample testing cartridges of the set ofsample testing cartridges; transmitting, by the analyzer, thecalibration verification data to a data manager; receiving, at theanalyzer, a message from the data manager, wherein the message includesa data table comprising: (i) an identification number associated witheach analyzer within the group of analyzers including the analyzer, and(ii) a compliance status for each analyzer within the group of analyzersincluding the analyzer, wherein the compliance status is a binarydetermination of either compliant or non-compliant for each analyzerwithin the group of analyzers; storing, at the analyzer, the data tablein memory of the analyzer such that the analyzer is continually capableof obtaining the compliance status for the analyzer and other analyzerswithin the group of analyzers; obtaining, by the analyzer, thecompliance status for the analyzer from the data table stored in thememory of the analyzer based on an identification number associated withthe analyzer; when the compliance status obtained from the data tableindicates the analyzer is in compliance, enable use of the analyzer forperforming one or more analytical tests on biological samples; and whenthe compliance status obtained from the data table indicates theanalyzer is not in compliance, at least partially disable use of theanalyzer for performing the one or more analytical tests on thebiological samples.